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pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization. J Pharmacokinet Pharmacodyn. 2024 Dec; 51(6):785-796.
Li X, Sale M, Nieforth K, Craig J, Wang F, Solit D, Feng K, Hu M, Bies R, Zhao L. PMID: 38941056; PMCID: PMC11579193.
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Commentary on 'Exploration of suitable pharmacodynamic parameters for acarbose bioequivalence evaluation: A series of clinical trials with branded acarbose' by Jie Huang et al. Br J Clin Pharmacol. 2024 Sep; 90(9):2320-2322.
Zhang P, Lee J, Feng K, Babiskin A, Yoon M, Fang L, Zhao L. PMID: 38922996.
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Humans
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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances. J Pharm Sci. 2024 Sep; 113(9):2708-2714.
Lu D, Rege B, Raw A, Yang J, Alam K, Bode C, Zhao L, Faustino P, Wu F, Shakleya D, Nickum E, Li BV, Wang R, Stier E, Miezeiewski B, Patel R, Boam A, Lionberger R, Keire D, Yu L. PMID: 38862090.
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HumansCells
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Model-based bioequivalence approach for sparse pharmacokinetic bioequivalence studies: Model selection or model averaging? Stat Med. 2024 Aug 15; 43(18):3403-3416.
Philipp M, Tessier A, Donnelly M, Fang L, Feng K, Zhao L, Grosser S, Sun G, Sun W, Mentré F, Bertrand J. PMID: 38847215.
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Humans
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Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters. Pharmaceutics. 2024 May 10; 16(5).
Kulkarni CP, Yang J, Koleske ML, Lara G, Alam K, Raw A, Rege B, Zhao L, Lu D, Zhang L, Yu LX, Lionberger RA, Giacomini KM, Kroetz DL, Yee SW. PMID: 38794309; PMCID: PMC11124870.
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Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability. AAPS J. 2024 04 26; 26(3):56.
Li S, Feng K, Lee J, Gong Y, Wu F, Newman B, Yoon M, Fang L, Zhao L, Gobburu JVS. PMID: 38671158.
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Humans
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Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023. AAPS J. 2024 04 24; 26(3):55.
Tsakalozou E, Gong Y, Babiskin A, Hu M, Mousa Y, Walenga R, Wu F, Yoon M, Raney SG, Polli JE, Schwendeman A, Krishnan V, Fang L, Zhao L. PMID: 38658449.
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Humans
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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop. AAPS J. 2024 04 08; 26(3):45.
Pal A, Wu F, Walenga R, Tsakalozou E, Alam K, Gong Y, Zhao L, Fang L. PMID: 38589695.
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1 Fields:
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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA. AAPS J. 2024 02 27; 26(2):28.
Fang L, Gong Y, Hooker AC, Lukacova V, Rostami-Hodjegan A, Sale M, Grosser S, Jereb R, Savic R, Peck C, Zhao L. PMID: 38413548.
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2 Fields:
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Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype-Guided Precision Medicine. Clin Pharmacol Ther. 2024 02; 115(2):169-172.
Zhao L, Giacomini KM, van der Graaf PH. PMID: 38252417.
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Humans
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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products. AAPS J. 2024 01 24; 26(1):19.
Wu F, Mousa Y, Jereb R, Batchelor H, Chakraborty S, Heimbach T, Stier E, Kesisoglou F, Kollipara S, Zhang L, Zhao L. PMID: 38267737.
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3 Fields:
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Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development. AAPS J. 2024 01 24; 26(1):15.
Gong Y, Barretto FX, Tsong Y, Mousa Y, Ren K, Kozak D, Shen M, Hu M, Zhao L. PMID: 38267593.
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1 Fields:
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Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report. AAPS J. 2024 01 10; 26(1):14.
Tsakalozou E, Fang L, Bi Y, van den Heuvel M, Ahmed T, Tsang YC, Lionberger R, Rostami-Hodjegan A, Zhao L. PMID: 38200397.
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PubMed Mentions:
3 Fields:
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pyDarwin: A Machine Learning Enhanced Automated Nonlinear Mixed-Effect Model Selection Toolbox. Clin Pharmacol Ther. 2024 04; 115(4):758-773.
Li X, Sale M, Nieforth K, Bigos KL, Craig J, Wang F, Feng K, Hu M, Bies R, Zhao L. PMID: 38037471.
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Humans
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Use of physiologically-based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended-release nifedipine. CPT Pharmacometrics Syst Pharmacol. 2024 02; 13(2):247-256.
Tan ML, Gao Z, Babiskin A, Kim MJ, Fang L, Zhang L, Zhao L. PMID: 38130031; PMCID: PMC10864925.
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PubMed Mentions:
2 Fields:
Translation:
HumansCells
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Leveraging GPT-4 for food effect summarization to enhance product-specific guidance development via iterative prompting. J Biomed Inform. 2023 12; 148:104533.
Shi Y, Ren P, Wang J, Han B, ValizadehAslani T, Agbavor F, Zhang Y, Hu M, Zhao L, Liang H. PMID: 37918623.
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Effect of Omeprazole Administration on the Pharmacokinetics of Oral Extended-Release Nifedipine in Healthy Subjects. Clin Pharmacol Ther. 2023 11; 114(5):1134-1141.
Zhao L, Sun D, Tan ML, Xu M, Kinjo M, Feng K, Wang H, Lionberger R. PMID: 37669218.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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Landscape Analysis of Generic Availability for Oncologic Drugs. Ther Innov Regul Sci. 2023 11; 57(6):1279-1286.
Kumar V, Wang F, Hu M, Kluetz P, Zhao L. PMID: 37561261.
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Humans
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PharmBERT: a domain-specific BERT model for drug labels. Brief Bioinform. 2023 07 20; 24(4).
ValizadehAslani T, Shi Y, Ren P, Wang J, Zhang Y, Hu M, Zhao L, Liang H. PMID: 37317617.
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7 Fields:
Translation:
Humans
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Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study. AAPS J. 2023 06 29; 25(4):67.
Pawar G, Wu F, Zhao L, Fang L, Burckart GJ, Feng K, Mousa YM, Al Shoyaib A, Jones MC, Batchelor HK. PMID: 37386339.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies. CPT Pharmacometrics Syst Pharmacol. 2023 07; 12(7):904-915.
Tardivon C, Loingeville F, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Bertrand J. PMID: 37114321; PMCID: PMC10349197.
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PubMed Mentions:
3 Fields:
Translation:
Humans
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Computational Model of In Vivo Corneal Pharmacokinetics and Pharmacodynamics of Topically Administered Ophthalmic Drug Products. Pharm Res. 2023 Apr; 40(4):961-975.
German C, Chen Z, Przekwas A, Walenga R, Babiskin A, Zhao L, Fan J, Tan ML. PMID: 36959411.
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PubMed Mentions:
1 Fields:
Translation:
HumansAnimals
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Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):624-630.
Gong Y, Zhang P, Yoon M, Zhu H, Kohojkar A, Hooker AC, Ducharme MP, Gobburu J, Cellière G, Gajjar P, Li BV, Velagapudi R, Tsang YC, Schwendeman A, Polli J, Fang L, Lionberger R, Zhao L. PMID: 36710372; PMCID: PMC10196434.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):552-555.
Yoon M, Babiskin A, Hu M, Wu F, Raney SG, Fang L, Zhao L. PMID: 36756902; PMCID: PMC10196404.
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PubMed Mentions:
3 Fields:
Translation:
HumansCells
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Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):619-623.
Babiskin A, Wu F, Mousa Y, Tan ML, Tsakalozou E, Walenga RL, Yoon M, Raney SG, Polli JE, Schwendeman A, Krishnan V, Fang L, Zhao L. PMID: 36631942; PMCID: PMC10196436.
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7 Fields:
Translation:
Humans
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Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):610-618.
Al Shoyaib A, Riedmaier AE, Kumar A, Roy P, Parrott NJ, Fang L, Tampal N, Yang Y, Jereb R, Zhao L, Wu F. PMID: 36597353; PMCID: PMC10196427.
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PubMed Mentions:
5 Fields:
Translation:
Humans
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Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):585-597.
Wu F, Mousa Y, Raines K, Bode C, Tsang YC, Cristofoletti R, Zhang H, Heimbach T, Fang L, Kesisoglou F, Mitra A, Polli J, Kim MJ, Fan J, Zolnik BS, Sun D, Zhang Y, Zhao L. PMID: 36530026; PMCID: PMC10196428.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Mechanistic modeling of generic orally inhaled drug products: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 05; 12(5):560-574.
Walenga RL, Butler C, Craven BA, Longest PW, Mohamed R, Newman B, Olsson B, Hochhaus G, Li BV, Luke MC, Zhao L, Przekwas A, Lionberger R. PMID: 36330693; PMCID: PMC10196431.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study. Epilepsia. 2023 01; 64(1):152-161.
Fang L, Li Z, Kinjo M, Lomonaco S, Zheng N, Jiang W, Zhao L. PMID: 36259141.
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Humans
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Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation. Pharm Res. 2023 Feb; 40(2):431-447.
Le Merdy M, AlQaraghuli F, Tan ML, Walenga R, Babiskin A, Zhao L, Lukacova V. PMID: 36151444; PMCID: PMC9944674.
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PubMed Mentions:
6 Fields:
Translation:
HumansAnimals
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Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies. J Pharmacokinet Pharmacodyn. 2022 10; 49(5):557-577.
Guhl M, Mercier F, Hofmann C, Sharan S, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Comets E, Bertrand J. PMID: 36112338; PMCID: PMC9483500.
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2 Fields:
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Improved GSimp: A Flexible Missing Value Imputation Method to Support Regulatory Bioequivalence Assessment. Ann Biomed Eng. 2023 Jan; 51(1):163-173.
Wang J, Gong X, Hu M, Zhao L. PMID: 36107365.
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Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective. Adv Drug Deliv Rev. 2022 11; 190:114526.
Newman B, Babiskin A, Bielski E, Boc S, Dhapare S, Fang L, Feibus K, Kaviratna A, Li BV, Luke MC, Ma T, Spagnola M, Walenga RL, Wang Z, Zhao L, El-Gendy N, Bertha CM, Abd El-Shafy M, Gaglani DK. PMID: 36067967.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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Usage of Compartmental Models in Predicting COVID-19 Outbreaks. AAPS J. 2022 09 02; 24(5):98.
Zhang P, Feng K, Gong Y, Lee J, Lomonaco S, Zhao L. PMID: 36056223; PMCID: PMC9439263.
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PubMed Mentions:
6 Fields:
Translation:
HumansCellsPHPublic Health
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Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies. AAPS J. 2022 09 01; 24(5):97.
Peck C, Campbell G, Yoo I, Feng K, Hu M, Zhao L. PMID: 36050426.
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Humans
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Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective. Adv Drug Deliv Rev. 2022 10; 189:114519.
El-Gendy N, Bertha CM, Abd El-Shafy M, Gaglani DK, Babiskin A, Bielski E, Boc S, Dhapare S, Fang L, Feibus K, Kaviratna A, Li BV, Luke MC, Ma T, Newman B, Spagnola M, Walenga RL, Zhao L. PMID: 36038083.
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3 Fields:
Translation:
Humans
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Decoding kinase-adverse event associations for small molecule kinase inhibitors. Nat Commun. 2022 Jul 27; 13(1):4349.
Gong X, Hu M, Liu J, Kim G, Xu J, McKee A, Palmby T, de Claro RA, Zhao L. PMID: 35896580; PMCID: PMC9329312.
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Concentration-Response Model of Immediate Release Oxycodone Drug Liking by Different Routes of Abuse. Pain Med. 2022 07 01; 23(7):1311-1322.
Nallani SC, Li W, Calderon SN, Fields E, Roca RA, Xu Y, Zhao L, Fang L, Sahajwalla CG, Zineh I. PMID: 34865125.
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Humans
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A randomized, cross-over trial of metoprolol succinate formulations to evaluate PK and PD end points for therapeutic equivalence. Clin Transl Sci. 2022 07; 15(7):1764-1775.
Mosley SA, Kim S, El Rouby N, Lingineni K, Esteban VV, Gong Y, Chen Y, Estores D, Feng K, Kim H, Kinjo M, Langaee T, Li Z, Schmidt SOF, Johnson JA, Frye RF, Fang LL, Zhao L, Binkley PF, Schmidt S, Cavallari LH. PMID: 35488487; PMCID: PMC9283731.
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1 Fields:
Translation:
Humans
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Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making. Pharm Res. 2022 Aug; 39(8):1669-1680.
Madabushi R, Seo P, Zhao L, Tegenge M, Zhu H. PMID: 35552984; PMCID: PMC9097888.
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32 Fields:
Translation:
HumansAnimals
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Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System. AAPS J. 2022 05 02; 24(3):63.
Sharan S, Choi S, Zou Y, Wang Y, Kim MJ, Fang L, Choi S, Makhlouf F, Grosser SC, Zhang X, Zhao L. PMID: 35501412.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches. CPT Pharmacometrics Syst Pharmacol. 2022 07; 11(7):833-842.
Gong Y, Feng K, Zhang P, Lee J, Pan Y, Zhang Z, Ni Z, Bai T, Yoon M, Li B, Kim CY, Fang L, Zhao L. PMID: 35411692; PMCID: PMC9111087.
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PubMed Mentions:
1 Fields:
Translation:
HumansPHPublic Health
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Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Intern Med. 2022 04 01; 182(4):418-425.
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. PMID: 35226058; PMCID: PMC8886450.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products. Clin Pharmacol Ther. 2022 11; 112(5):982-989.
Lee J, Feng K, Conti DS, Walenga R, Wientjes M, Wang H, Newman B, Han L, Dhapare S, Bielski E, Babiskin A, Wu F, Donnelly M, Kim MJ, Jiang W, Luke MC, Fang L, Zhao L. PMID: 35133652.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA. Ther Innov Regul Sci. 2022 03; 56(2):346-357.
Wang Z, Ahluwalia SK, Newman B, Dhapare S, Zhao L, Luke MC. PMID: 35118630; PMCID: PMC8812951.
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3 Fields:
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Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults. Endocrine. 2022 05; 76(2):349-358.
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. PMID: 35107758; PMCID: PMC9210352.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Efficient model-based bioequivalence testing. Biostatistics. 2022 01 13; 23(1):314-327.
Möllenhoff K, Loingeville F, Bertrand J, Nguyen TT, Sharan S, Zhao L, Fang L, Sun G, Grosser S, Mentré F, Dette H. PMID: 32696053.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Heterogeneous treatment effect analysis based on machine-learning methodology. CPT Pharmacometrics Syst Pharmacol. 2021 11; 10(11):1433-1443.
Gong X, Hu M, Basu M, Zhao L. PMID: 34716669; PMCID: PMC8592515.
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10 Fields:
Translation:
Humans
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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary. CPT Pharmacometrics Syst Pharmacol. 2021 11; 10(11):1271-1275.
Jean D, Naik K, Milligan L, Hall S, Mei Huang S, Isoherranen N, Kuemmel C, Seo P, Tegenge MA, Wang Y, Yang Y, Zhang X, Zhao L, Zhao P, Benjamin J, Bergman K, Grillo J, Madabushi R, Wu F, Zhu H, Zineh I. PMID: 34536337; PMCID: PMC8592512.
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PubMed Mentions:
10 Fields:
Translation:
Humans
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Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance. EClinicalMedicine. 2021 Nov; 41:101135.
Zhao L, Li Z, Fang L, Kim MJ, Nallani SC, Sahajwalla CG, Calderon SN, Roca RA, Feng K, Zineh I, Lionberger R. PMID: 34585126; PMCID: PMC8455721.
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PubMed Mentions:
1
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Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations. Clin Pharmacol Ther. 2022 05; 111(5):1036-1049.
Tsakalozou E, Alam K, Babiskin A, Zhao L. PMID: 34231211.
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12 Fields:
Translation:
Humans
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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial. JAMA. 2021 07 20; 326(3):240-249.
Florian J, Matta MK, DePalma R, Gershuny V, Patel V, Hsiao CH, Zusterzeel R, Rouse R, Prentice K, Nalepinski CG, Kim I, Yi S, Zhao L, Yoon M, Selaya S, Keire D, Korvick J, Strauss DG. PMID: 34180947; PMCID: PMC8240005.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine. 2021 12; 74(3):592-602.
Brito JP, Ross JS, Deng Y, Sangaralingham L, Graham DJ, Qiang Y, Wang Z, Yao X, Zhao L, Smallridge RC, Bernet V, Shah ND, Lipska KJ. PMID: 34089480; PMCID: PMC9210353.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users. Clin Transl Sci. 2021 09; 14(5):1977-1987.
Raofi S, Kinjo M, Sun D, Li Z, Boyce H, Natarajan K, Frost M, Zhao L, Luke M, Lionberger R, Kelsh D, Kim MJ. PMID: 33982418; PMCID: PMC8504826.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Virtual screening FDA approved drugs against multiple targets of SARS-CoV-2. Clin Transl Sci. 2021 05; 14(3):1123-1132.
Liang H, Zhao L, Gong X, Hu M, Wang H. PMID: 33606912; PMCID: PMC8014887.
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PubMed Mentions:
9 Fields:
Translation:
HumansCells
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Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help. Biopharm Drug Dispos. 2021 Apr; 42(4):118-127.
Wu F, Cristofoletti R, Zhao L, Rostami-Hodjegan A. PMID: 33759204.
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PubMed Mentions:
7 Fields:
Translation:
Humans
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Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products. AAPS J. 2021 04 21; 23(3):57.
Pawar G, Wu F, Zhao L, Fang L, Burckart GJ, Feng K, Mousa YM, Naumann F, Batchelor HK. PMID: 33884497; PMCID: PMC8060189.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1. CPT Pharmacometrics Syst Pharmacol. 2021 05; 10(5):399-411.
Tsakalozou E, Babiskin A, Zhao L. PMID: 33547863; PMCID: PMC8129718.
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15 Fields:
Translation:
Humans
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Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective. Clin Pharmacol Ther. 2021 10; 110(4):880-887.
Fang L, Uppoor R, Xu M, Sharan S, Zhu H, Tampal N, Li B, Zhang L, Lionberger R, Zhao L. PMID: 33492710.
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Physiologically Based Pharmacokinetic Modeling Approach to Identify the Drug-Drug Interaction Mechanism of Nifedipine and a Proton Pump Inhibitor, Omeprazole. Eur J Drug Metab Pharmacokinet. 2021 Jan; 46(1):41-51.
Le Merdy M, Tan ML, Sun D, Ni Z, Lee SC, Babiskin A, Zhao L. PMID: 33064292.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence. Clin Pharmacol Ther. 2021 11; 110(5):1190-1195.
Lee J, Gong Y, Bhoopathy S, DiLiberti CE, Hooker AC, Rostami-Hodjegan A, Schmidt S, Suarez-Sharp S, Lukacova V, Fang L, Zhao L. PMID: 33236362.
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PubMed Mentions:
3 Fields:
Translation:
Humans
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Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States. J Clin Pharmacol. 2020 12; 60 Suppl 2:S34-S38.
Sharan S, Wang Y, Donnelly M, Zou Y, Fang L, Kim MJ, Zhao L. PMID: 33274507.
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PubMed Mentions:
1 Fields:
Translation:
HumansPHPublic Health
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Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions. J Clin Pharmacol. 2020 12; 60 Suppl 2:S26-S33.
Donnelly M, Tsakalozou E, Sharan S, Straubinger T, Bies R, Zhao L. PMID: 33274513.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens. J Clin Pharmacol. 2020 12; 60 Suppl 2:S103-S109.
Fang L, Sonvg X, Ji P, Wang Y, Maynard J, Yim S, Sahajwalla C, Xu M, Kim MJ, Zhao L. PMID: 33274512.
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PubMed Mentions:
3 Fields:
Translation:
Humans
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Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations. Pharm Res. 2020 Nov 19; 37(12):245.
Le Merdy M, Spires J, Lukacova V, Tan ML, Babiskin A, Xu X, Zhao L, Bolger MB. PMID: 33215336; PMCID: PMC7677276.
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PubMed Mentions:
7 Fields:
Translation:
Animals
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Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype-Derived Activity Scores. CPT Pharmacometrics Syst Pharmacol. 2020 12; 9(12):678-685.
Thomas CD, Mosley SA, Kim S, Lingineni K, El Rouby N, Langaee TY, Gong Y, Wang D, Schmidt SO, Binkley PF, Estores DS, Feng K, Kim H, Kinjo M, Li Z, Fang L, Chapman AB, Cooper-DeHoff RM, Gums JG, Hamadeh IS, Zhao L, Schmidt S, Frye RF, Johnson JA, Cavallari LH. PMID: 33067866; PMCID: PMC7762806.
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11 Fields:
Translation:
HumansCTClinical Trials
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New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling. AAPS J. 2020 10 30; 22(6):141.
Loingeville F, Bertrand J, Nguyen TT, Sharan S, Feng K, Sun W, Han J, Grosser S, Zhao L, Fang L, Möllenhoff K, Dette H, Mentré F. PMID: 33125589.
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PubMed Mentions:
5 Fields:
Translation:
Humans
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Applications of Adaptive Designs in Generic Drug Development. Clin Pharmacol Ther. 2021 07; 110(1):32-35.
Lee J, Feng K, Xu M, Gong X, Sun W, Kim J, Zhang Z, Wang M, Fang L, Zhao L. PMID: 32940349.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations. AAPS J. 2020 08 10; 22(5):107.
Miao L, Mousa YM, Zhao L, Raines K, Seo P, Wu F. PMID: 32779046.
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PubMed Mentions:
15 Fields:
Translation:
Humans
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Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions. Ther Innov Regul Sci. 2020 11; 54(6):1372-1381.
Wittayanukorn S, Rosenberg M, Schick A, Hu M, Wang Z, Babiskin A, Lionberger R, Zhao L. PMID: 32495310.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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A novel quantification of information for longitudinal data analyzed by mixed-effects modeling. Pharm Stat. 2020 07; 19(4):388-398.
Yuan M, Li Y, Yang Y, Xu J, Tao F, Zhao L, Zhou H, Pinheiro J, Xu XS. PMID: 31989784.
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PubMed Mentions:
1 Fields:
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Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development. AAPS J. 2020 01 06; 22(2):26.
Le Merdy M, Tan ML, Babiskin A, Zhao L. PMID: 31907674.
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PubMed Mentions:
9 Fields:
Translation:
Animals
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Mathematical modeling of the heterogeneous distributions of nanomedicines in solid tumors. Eur J Pharm Biopharm. 2019 Sep; 142:153-164.
He H, Liu C, Liu Y, Liu X, Wu Y, Fan J, Zhao L, Cao Y. PMID: 31226367; PMCID: PMC6717548.
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PubMed Mentions:
7 Fields:
Translation:
Humans
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Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology. Clin Pharmacol Ther. 2019 07; 106(1):174-181.
Hu M, Babiskin A, Wittayanukorn S, Schick A, Rosenberg M, Gong X, Kim MJ, Zhang L, Lionberger R, Zhao L. PMID: 31009066.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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American Society for Clinical Pharmacology and Therapeutics 2019 Annual Meeting Pre-Conferences. CPT Pharmacometrics Syst Pharmacol. 2019 06; 8(6):333-335.
Bai JPF, Musante CJ, Petanceska S, Zhang L, Zhao L, Zhao P. PMID: 31087531; PMCID: PMC6617844.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products. CPT Pharmacometrics Syst Pharmacol. 2019 06; 8(6):347-351.
Zhao L, Seo P, Lionberger R. PMID: 31355547; PMCID: PMC6662325.
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PubMed Mentions:
11 Fields:
Translation:
Humans
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In Silico Methods for Development of Generic Drug-Device Combination Orally Inhaled Drug Products. CPT Pharmacometrics Syst Pharmacol. 2019 06; 8(6):359-370.
Walenga RL, Babiskin AH, Zhao L. PMID: 31044532; PMCID: PMC6618094.
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PubMed Mentions:
8 Fields:
Translation:
HumansPHPublic Health
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Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension. AAPS J. 2019 05 20; 21(4):65.
Le Merdy M, Fan J, Bolger MB, Lukacova V, Spires J, Tsakalozou E, Patel V, Xu L, Stewart S, Chockalingam A, Narayanasamy S, Rouse R, Matta M, Babiskin A, Kozak D, Choi S, Zhang L, Lionberger R, Zhao L. PMID: 31111305.
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PubMed Mentions:
16 Fields:
Translation:
HumansAnimals
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Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products. J Clin Pharmacol. 2019 09; 59(9):1252-1263.
Basu S, Yang H, Fang L, Gonzalez-Sales M, Zhao L, Trame MN, Lesko L, Schmidt S. PMID: 31087553.
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PubMed Mentions:
9 Fields:
Translation:
HumansCells
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Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study. J Clin Pharmacol. 2019 09; 59(9):1266-1274.
Kim S, Sharma VD, Lingineni K, Farhan N, Fang L, Zhao L, Brown JD, Cristofoletti R, Vozmediano V, Ait-Oudhia S, Lesko LJ, Trame MN, Schmidt S. PMID: 31087554.
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PubMed Mentions:
6 Fields:
Translation:
HumansCells
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Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations. J Clin Pharmacol. 2019 08; 59(8):1061-1069.
Kim H, Fang L, Yu J, Meng Z, Trame MN, Schmidt S, Lesko LJ, Zhao L. PMID: 30716169.
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PubMed Mentions:
2 Fields:
Translation:
HumansCTClinical Trials
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Generating Model Integrated Evidence for Generic Drug Development and Assessment. Clin Pharmacol Ther. 2019 02; 105(2):338-349.
Zhao L, Kim MJ, Zhang L, Lionberger R. PMID: 30414386.
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PubMed Mentions:
25 Fields:
Translation:
Humans
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Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs. Clin Pharmacol Ther. 2019 02; 105(2):411-416.
Jayachandran P, Okochi H, Frassetto LA, Park W, Fang L, Zhao L, Benet LZ. PMID: 30652304.
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PubMed Mentions:
4 Fields:
Translation:
HumansCTClinical Trials
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Comment on: "Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs". Drug Saf. 2018 12; 41(12):1419-1421.
Suggs CM, Levin RL, Mosholder AD, Swain RS, Zhao L. PMID: 30232739.
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PubMed Mentions:
1 Fields:
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A quick and accurate method for the estimation of covariate effects based on empirical Bayes estimates in mixed-effects modeling: Correction of bias due to shrinkage. Stat Methods Med Res. 2019 12; 28(12):3568-3578.
Yuan M, Xu XS, Yang Y, Xu J, Huang X, Tao F, Zhao L, Zhang L, Pinheiro J. PMID: 30409080.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time. J Pharm Sci. 2019 Jan; 108(1):620-629.
Walenga RL, Babiskin AH, Zhang X, Absar M, Zhao L, Lionberger RA. PMID: 30385283.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance. AAPS J. 2018 04 12; 20(3):62.
Hu M, Jiang X, Absar M, Choi S, Kozak D, Shen M, Weng YT, Zhao L, Lionberger R. PMID: 29651627.
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PubMed Mentions:
3 Fields:
Translation:
Humans
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Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop. Clin Pharmacol Ther. 2018 07; 104(1):27-30.
Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L. PMID: 29603191.
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PubMed Mentions:
12 Fields:
Translation:
Humans
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Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis. Clin Transl Sci. 2018 05; 11(3):305-311.
Gong X, Hu M, Zhao L. PMID: 29536640; PMCID: PMC5944589.
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PubMed Mentions:
13 Fields:
Translation:
Humans
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Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs. Curr Neurol Neurosci Rep. 2017 Sep 19; 17(11):82.
Li Z, Fang L, Jiang W, Kim MJ, Zhao L. PMID: 28929357.
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PubMed Mentions:
1 Fields:
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Humans
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Model-Based Assessment Using Conventional Bioequivalence Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement. J Clin Pharmacol. 2017 Dec; 57(12):1591-1599.
González-Sales M, Fang L, Kim MJ, Zhao L. PMID: 28926095.
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Humans
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Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors. AAPS J. 2017 09; 19(5):1479-1486.
Fan J, Zhang X, Zhao L. PMID: 28710684.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop. CPT Pharmacometrics Syst Pharmacol. 2017 08; 6(8):492-495.
Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, Lukacova V, Eissing T, Tsakalozou E, Zhao L, Lionberger R. PMID: 28571121; PMCID: PMC5572334.
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PubMed Mentions:
15 Fields:
Translation:
Humans
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Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products. AAPS J. 2017 07; 19(4):1045-1053.
Ni Z, Talattof A, Fan J, Tsakalozou E, Sharan S, Sun D, Wen H, Zhao L, Zhang X. PMID: 28357656.
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PubMed Mentions:
3 Fields:
Translation:
Cells
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FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Clin Cancer Res. 2017 Oct 01; 23(19):5666-5670.
Chuk MK, Chang JT, Theoret MR, Sampene E, He K, Weis SL, Helms WS, Jin R, Li H, Yu J, Zhao H, Zhao L, Paciga M, Schmiel D, Rawat R, Keegan P, Pazdur R. PMID: 28235882.
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PubMed Mentions:
38 Fields:
Translation:
HumansCTClinical Trials
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Dissolution Failure of Solid Oral Drug Products in Field Alert Reports. J Pharm Sci. 2017 05; 106(5):1302-1309.
Sun D, Hu M, Browning M, Friedman RL, Jiang W, Zhao L, Wen H. PMID: 28104414.
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PubMed Mentions:
2 Fields:
Translation:
Cells
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U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab. Clin Cancer Res. 2017 Jul 15; 23(14):3484-3488.
Hazarika M, Chuk MK, Theoret MR, Mushti S, He K, Weis SL, Putman AH, Helms WS, Cao X, Li H, Zhao H, Zhao L, Welch J, Graham L, Libeg M, Sridhara R, Keegan P, Pazdur R. PMID: 28087644.
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PubMed Mentions:
62 Fields:
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Humans
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Method to Assess Interactivity of Drugs with Nonparallel Concentration Effect Relationships. Curr Cancer Drug Targets. 2017; 17(8):735-755.
Zhao L, Au JL, Wientjes MG. PMID: 28359247; PMCID: PMC5623138.
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PubMed Mentions:
2 Fields:
Translation:
HumansCells
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Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses. AAPS J. 2016 11; 18(6):1500-1511.
Chow EC, Talattof A, Tsakalozou E, Fan J, Zhao L, Zhang X. PMID: 27520379.
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PubMed Mentions:
11 Fields:
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FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2015 Dec 01; 21(23):5205-8.
Nair A, Lemery SJ, Yang J, Marathe A, Zhao L, Zhao H, Jiang X, He K, Ladouceur G, Mitra AK, Zhou L, Fox E, Aungst S, Helms W, Keegan P, Pazdur R. PMID: 26324740.
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PubMed Mentions:
31 Fields:
Translation:
Humans
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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. Clin Cancer Res. 2015 Nov 01; 21(21):4760-6.
Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P. PMID: 26324739.
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PubMed Mentions:
137 Fields:
Translation:
HumansAnimals
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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. Clin Cancer Res. 2015 Oct 01; 21(19):4257-61.
Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. PMID: 26187614.
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PubMed Mentions:
247 Fields:
Translation:
HumansAnimals
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Quantitative characterization of circadian rhythm of pulmonary function in asthmatic patients treated with inhaled corticosteroids. J Pharmacokinet Pharmacodyn. 2015 Aug; 42(4):391-9.
Zhou D, Li H, Wang Y, Hochhaus G, Sinha V, Zhao L. PMID: 26099861.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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FDA Approval Summary: Ramucirumab for Gastric Cancer. Clin Cancer Res. 2015 Aug 01; 21(15):3372-6.
Casak SJ, Fashoyin-Aje I, Lemery SJ, Zhang L, Jin R, Li H, Zhao L, Zhao H, Zhang H, Chen H, He K, Dougherty M, Novak R, Kennett S, Khasar S, Helms W, Keegan P, Pazdur R. PMID: 26048277.
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PubMed Mentions:
44 Fields:
Translation:
HumansCTClinical Trials
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FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease. Clin Cancer Res. 2015 Mar 01; 21(5):950-4.
Deisseroth A, Ko CW, Nie L, Zirkelbach JF, Zhao L, Bullock J, Mehrotra N, Del Valle P, Saber H, Sheth C, Gehrke B, Justice R, Farrell A, Pazdur R. PMID: 25601959.
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PubMed Mentions:
56 Fields:
Translation:
HumansAnimals
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Clinical endpoint sensitivity in rheumatoid arthritis: modeling and simulation. J Pharmacokinet Pharmacodyn. 2014 Oct; 41(5):537-43.
Ma L, Zhao L, Xu Y, Yim S, Doddapaneni S, Sahajwalla CG, Wang Y, Ji P. PMID: 25283268.
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PubMed Mentions:
5 Fields:
Translation:
Humans
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The antibody drug absorption following subcutaneous or intramuscular administration and its mathematical description by coupling physiologically based absorption process with the conventional compartment pharmacokinetic model. J Clin Pharmacol. 2013 Mar; 53(3):314-25.
Zhao L, Ji P, Li Z, Roy P, Sahajwalla CG. PMID: 23426855.
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PubMed Mentions:
47 Fields:
Translation:
HumansCells
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Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development. J Pharm Sci. 2012 Dec; 101(12):4367-82.
Zhao L, Shang EY, Sahajwalla CG. PMID: 23018763.
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PubMed Mentions:
14 Fields:
Translation:
HumansAnimals
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Clinical pharmacology considerations in biologics development. Acta Pharmacol Sin. 2012 Nov; 33(11):1339-47.
Zhao L, Ren TH, Wang DD. PMID: 23001474; PMCID: PMC4011353.
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PubMed Mentions:
51 Fields:
Translation:
HumansAnimals
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Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children. Antimicrob Agents Chemother. 2012 Sep; 56(9):4927-36.
Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK. PMID: 22802243; PMCID: PMC3421858.
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PubMed Mentions:
69 Fields:
Translation:
HumansCells
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A new stochastic approach to multi-compartment pharmacokinetic models: probability of traveling route and distribution of residence time in linear and nonlinear systems. J Pharmacokinet Pharmacodyn. 2011 Feb; 38(1):83-104.
Zhao L, Li N, Yang H. PMID: 21165682.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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Comparison of methods for evaluating drug-drug interaction. Front Biosci (Elite Ed). 2010 01 01; 2(1):241-9.
Zhao L, Au JL, Wientjes MG. PMID: 20036874; PMCID: PMC2885905.
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PubMed Mentions:
94 Fields:
Translation:
HumansCells
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New developments in using stochastic recipe for multi-compartment model: inter-compartment traveling route, residence time, and exponential convolution expansion. Math Biosci Eng. 2009 Jul; 6(3):663-82.
Zhao L. PMID: 19566134.
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PubMed Mentions:
2 Fields:
Translation:
Humans
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Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr; 28(4):267-72.
Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, Losonsky GA, Motavizumab Study Group. PMID: 19258920.
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PubMed Mentions:
18 Fields:
Translation:
HumansCTClinical Trials
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Evaluation of combination chemotherapy: integration of nonlinear regression, curve shift, isobologram, and combination index analyses. Clin Cancer Res. 2004 Dec 01; 10(23):7994-8004.
Zhao L, Wientjes MG, Au JL. PMID: 15585635.
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PubMed Mentions:
155 Fields:
Translation:
AnimalsCells