Liang Zhao, PhD, MAS, MBA

Title(s)Professor, Bioengineering
SchoolSchool of Pharmacy
Address600 16th Street, #N472C
San Francisco CA 94158
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    Collapse Biography 
    Collapse Education and Training
    China Pharmaceutical University, Nanjing, ChinaBS1995Pharmaceutics
    Shanghai Medical University (Currently College of Pharmacy, Fudan University), Shanghai, ChinaMS1998Pharmaceutics
    Ohio State University College of Pharmacy, Columbus, OHPhD2003Pharmaceutical Sciences
    Ohio State University, Columbus, OH MAS2004Applied Statistics
    University of Cambridge Judge Business School, Cambridge, UKMBA2011Management
    Collapse Awards and Honors
    China Society for Industrial and Applied Mathematics1993Awards in Chinese Mathematical Contest in Modeling; Team Head of China Pharmaceutical Univ.; First S
    Consortium for Mathematics and its Applications, US1995Team Head of China Pharmaceutical Univ., Successful Participant in the 11th American Mathematical Co
    China Pharmaceutical University1995Outstanding Graduate
    Shanghai Medical University1998Outstanding Dissertation
    Pharmaceutical Research Institute at Bristol Myers Squibb2006Pharmaceutical Research Institute Star Award
    Pharmaceutical Research Institute at Bristol Myers Squibb2006SCiX Successful Story
    Judge Business School, University of Cambridge2011Academic Award for Executive MBA Class 2009
    CDER, FDA201130+ FDA CDER team and Individual Awards
    FDA2021Commissioner's Special Citation
    Victims' Rights Foundation2020Humanitarian Award
    American Society for Clinical Pharmacology & Therapeutics (ASCPT)2023Gary Neil Prize for Innovation in Drug Development
    FDA2024FDA Group Recognition Award

    Collapse Overview 
    Collapse Overview
    Liang Zhao, PhD, MAS, MBA, is a professor in the Department of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine at the University of California, San Francisco (UCSF). He previously served as director of the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards in the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) from 2015 to 2024. He has demonstrated excellence and leadership in drug development and regulatory science in regulatory and industrial settings for new and generic drugs during his professional tenure of over 19 years, including in: Pharsight as an associate consultant, BMS as a research investigator, MedImmune as an associate director, the FDA as clinical pharmacology reviewer and Pharmacometrics team leader. He started several regulatory initiatives including concepting model master files for model sharing and implemented model-integrated evidence for generic product development and approval. Zhao has also introduced a broad array of innovative tools in the realm of drug deliveries and bioequivalence assessment, as well as big data tools including machine learning to pharmacometrics.

    Prior to joining UCSF, he had also served on the executive board for the newly established Quantitative Medicine Center of Excellence in the FDA and briefly as chair for the FDA Modeling & Simulation Working Group. He has published over 120 articles and book chapters in prestigious journals and in 2023 received the Gary Neil Prize for Innovation in Drug Development from the American Society for Clinical Pharmacology & Therapeutics.

    The Zhao Lab advances drug development and regulatory science through cutting-edge research in pharmacometrics, drug delivery modeling, and artificial intelligence (AI)-based tools that will closely impact drug development and regulatory decision-making.

    Collapse Bibliographic 
    Collapse Publications
    Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Researchers can login to make corrections and additions, or contact us for help. to make corrections and additions.
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    Altmetrics Details PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
    1. 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.
      View in: PubMed   Mentions:    Fields:    
    2. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    3. 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.
      View in: PubMed   Mentions:    Fields:    Translation:HumansCells
    4. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    5. 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.
      View in: PubMed   Mentions:
    6. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    7. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    8. 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.
      View in: PubMed   Mentions: 1     Fields:    
    9. 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.
      View in: PubMed   Mentions: 2     Fields:    
    10. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    11. 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.
      View in: PubMed   Mentions: 3     Fields:    
    12. 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.
      View in: PubMed   Mentions: 1     Fields:    
    13. 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.
      View in: PubMed   Mentions: 3     Fields:    
    14. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    15. 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.
      View in: PubMed   Mentions: 2     Fields:    Translation:HumansCells
    16. 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.
      View in: PubMed   Mentions:    Fields:    
    17. 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.
      View in: PubMed   Mentions: 4     Fields:    Translation:Humans
    18. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    19. 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.
      View in: PubMed   Mentions: 7     Fields:    Translation:Humans
    20. 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.
      View in: PubMed   Mentions: 4     Fields:    Translation:Humans
    21. 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.
      View in: PubMed   Mentions: 3     Fields:    Translation:Humans
    22. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:HumansAnimals
    23. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    24. 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.
      View in: PubMed   Mentions: 3     Fields:    Translation:HumansCells
    25. 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.
      View in: PubMed   Mentions: 7     Fields:    Translation:Humans
    26. 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.
      View in: PubMed   Mentions: 5     Fields:    Translation:Humans
    27. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    28. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    29. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    30. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:HumansAnimals
    31. 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.
      View in: PubMed   Mentions: 2     Fields:    
    32. 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.
      View in: PubMed   Mentions:    Fields:    
    33. 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.
      View in: PubMed   Mentions: 2     Fields:    Translation:Humans
    34. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:HumansCellsPHPublic Health
    35. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    36. 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.
      View in: PubMed   Mentions: 3     Fields:    Translation:Humans
    37. 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.
      View in: PubMed   Mentions:    Fields:    
    38. 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.
      View in: PubMed   Mentions:    Fields:    Translation:Humans
    39. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    40. 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.
      View in: PubMed   Mentions: 32     Fields:    Translation:HumansAnimals
    41. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    42. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:HumansPHPublic Health
    43. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    44. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    45. 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.
      View in: PubMed   Mentions: 3     Fields:    
    46. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    47. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    48. 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.
      View in: PubMed   Mentions: 10     Fields:    Translation:Humans
    49. 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.
      View in: PubMed   Mentions: 10     Fields:    Translation:Humans
    50. 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.
      View in: PubMed   Mentions: 1  
    51. 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.
      View in: PubMed   Mentions: 12     Fields:    Translation:Humans
    52. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    53. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    54. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    55. 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.
      View in: PubMed   Mentions: 9     Fields:    Translation:HumansCells
    56. 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.
      View in: PubMed   Mentions: 7     Fields:    Translation:Humans
    57. 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.
      View in: PubMed   Mentions: 4     Fields:    Translation:Humans
    58. 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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    61. 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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    62. 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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    64. 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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    66. 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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    69. 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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    70. 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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    71. 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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    73. 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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    75. 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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    77. 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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    78. 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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    79. 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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    81. 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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    84. 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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    86. 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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    87. 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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    89. 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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    95. 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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    101. 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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    104. 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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    105. 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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    106. 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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    107. 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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    110. 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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    112. 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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    113. 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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    114. 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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    115. 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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