Liang Zhao, PhD, MAS, MBA

Professor
Department of Bioengineering and Therapeutic Sciences
Zhao
[email protected]
600 16th Street, Rm N472C
San Francisco, CA 94158
United States

Links

UCSF Profiles

Biography

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.

Research keywords

  • Mechanistic Models and Strategies for Brain Drug Delivery
  • Regulatory Science
  • Modeling and Simulation
  • Artificial Intelligence-Driven Drug Discovery and Development
  • Drug and Narcotic Control
  • drug interactions
  • Biological Availability
  • Drugs, Generic
  • Pharmacology, Clinical
  • Therapeutic Equivalency
  • Computer Simulation
  • United States Food and Drug Administration
  • Research Report
  • Drug Approval
  • Biological Models
  • Ocular Absorption
  • Eye
  • Nifedipine
  • Omeprazole
1. FDA Group Recognition Award, FDA, 2024
2. Gary Neil Prize for Innovation in Drug Development, American Society for Clinical Pharmacology & Therapeutics (ASCPT), 2023
3. Commissioner's Special Citation, FDA, 2021
4. Humanitarian Award, Victims' Rights Foundation, 2020
5. 30+ FDA CDER team and Individual Awards, CDER, FDA, 2011
6. Academic Award for Executive MBA Class 2009, Judge Business School, University of Cambridge, 2011
7. Pharmaceutical Research Institute Star Award, Pharmaceutical Research Institute at Bristol Myers Squibb, 2006
8. SCiX Successful Story, Pharmaceutical Research Institute at Bristol Myers Squibb, 2006
9. Outstanding Dissertation, Shanghai Medical University, 1998
10. Outstanding Graduate, China Pharmaceutical University, 1995
11. Team Head of China Pharmaceutical Univ., Successful Participant in the 11th American Mathematical Co, Consortium for Mathematics and its Applications, US, 1995
12. Awards in Chinese Mathematical Contest in Modeling; Team Head of China Pharmaceutical Univ.; First S, China Society for Industrial and Applied Mathematics, 1993

Publications

Li X, Sale M, Nieforth K, Craig J, Wang F, Solit D, Feng K, Hu M, Bies R, Zhao L. pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization. J Pharmacokinet Pharmacodyn. 2024 Jun 28.
Zhang P, Lee J, Feng K, Babiskin A, Yoon M, Fang L, Zhao L. 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.
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. Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances. J Pharm Sci. 2024 Sep; 113(9):2708-2714.
Philipp M, Tessier A, Donnelly M, Fang L, Feng K, Zhao L, Grosser S, Sun G, Sun W, Mentré F, Bertrand J. Model-based bioequivalence approach for sparse pharmacokinetic bioequivalence studies: Model selection or model averaging? Stat Med. 2024 Aug 15; 43(18):3403-3416.
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. Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters. Pharmaceutics. 2024 May 10; 16(5).
Li S, Feng K, Lee J, Gong Y, Wu F, Newman B, Yoon M, Fang L, Zhao L, Gobburu JVS. Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability. AAPS J. 2024 Apr 26; 26(3):56.
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. Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023. AAPS J. 2024 Apr 24; 26(3):55.
Pal A, Wu F, Walenga R, Tsakalozou E, Alam K, Gong Y, Zhao L, Fang L. 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 Apr 08; 26(3):45.
Fang L, Gong Y, Hooker AC, Lukacova V, Rostami-Hodjegan A, Sale M, Grosser S, Jereb R, Savic R, Peck C, Zhao L. The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA. AAPS J. 2024 02 27; 26(2):28.
Zhao L, Giacomini KM, van der Graaf PH. 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.
Gong Y, Barretto FX, Tsong Y, Mousa Y, Ren K, Kozak D, Shen M, Hu M, Zhao L. Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development. AAPS J. 2024 Jan 24; 26(1):15.
Wu F, Mousa Y, Jereb R, Batchelor H, Chakraborty S, Heimbach T, Stier E, Kesisoglou F, Kollipara S, Zhang L, Zhao L. Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products. AAPS J. 2024 Jan 24; 26(1):19.
Tsakalozou E, Fang L, Bi Y, van den Heuvel M, Ahmed T, Tsang YC, Lionberger R, Rostami-Hodjegan A, Zhao L. Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report. AAPS J. 2024 Jan 10; 26(1):14.
Li X, Sale M, Nieforth K, Bigos KL, Craig J, Wang F, Feng K, Hu M, Bies R, Zhao L. pyDarwin: A Machine Learning Enhanced Automated Nonlinear Mixed-Effect Model Selection Toolbox. Clin Pharmacol Ther. 2024 Apr; 115(4):758-773.
Tan ML, Gao Z, Babiskin A, Kim MJ, Fang L, Zhang L, Zhao L. 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 Feb; 13(2):247-256.
Shi Y, Ren P, Wang J, Han B, ValizadehAslani T, Agbavor F, Zhang Y, Hu M, Zhao L, Liang H. Leveraging GPT-4 for food effect summarization to enhance product-specific guidance development via iterative prompting. J Biomed Inform. 2023 Dec; 148:104533.
Zhao L, Sun D, Tan ML, Xu M, Kinjo M, Feng K, Wang H, Lionberger R. Effect of Omeprazole Administration on the Pharmacokinetics of Oral Extended-Release Nifedipine in Healthy Subjects. Clin Pharmacol Ther. 2023 Nov; 114(5):1134-1141.
Kumar V, Wang F, Hu M, Kluetz P, Zhao L. Landscape Analysis of Generic Availability for Oncologic Drugs. Ther Innov Regul Sci. 2023 Nov; 57(6):1279-1286.
ValizadehAslani T, Shi Y, Ren P, Wang J, Zhang Y, Hu M, Zhao L, Liang H. PharmBERT: a domain-specific BERT model for drug labels. Brief Bioinform. 2023 Jul 20; 24(4).
Pawar G, Wu F, Zhao L, Fang L, Burckart GJ, Feng K, Mousa YM, Al Shoyaib A, Jones MC, Batchelor HK. 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 Jun 29; 25(4):67.
Tardivon C, Loingeville F, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Bertrand J. Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies. CPT Pharmacometrics Syst Pharmacol. 2023 Jul; 12(7):904-915.
German C, Chen Z, Przekwas A, Walenga R, Babiskin A, Zhao L, Fan J, Tan ML. Computational Model of In Vivo Corneal Pharmacokinetics and Pharmacodynamics of Topically Administered Ophthalmic Drug Products. Pharm Res. 2023 Apr; 40(4):961-975.
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. 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 May; 12(5):624-630.
Yoon M, Babiskin A, Hu M, Wu F, Raney SG, Fang L, Zhao L. Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery. CPT Pharmacometrics Syst Pharmacol. 2023 May; 12(5):552-555.
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. Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview. CPT Pharmacometrics Syst Pharmacol. 2023 May; 12(5):619-623.
Al Shoyaib A, Riedmaier AE, Kumar A, Roy P, Parrott NJ, Fang L, Tampal N, Yang Y, Jereb R, Zhao L, Wu F. Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 May; 12(5):610-618.
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. Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 May; 12(5):585-597.
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. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023 May; 12(5):560-574.
Fang L, Li Z, Kinjo M, Lomonaco S, Zheng N, Jiang W, Zhao L. Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study. Epilepsia. 2023 Jan; 64(1):152-161.
Le Merdy M, AlQaraghuli F, Tan ML, Walenga R, Babiskin A, Zhao L, Lukacova V. Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation. Pharm Res. 2023 Feb; 40(2):431-447.
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. Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies. J Pharmacokinet Pharmacodyn. 2022 Oct; 49(5):557-577.
Wang J, Gong X, Hu M, Zhao L. Improved GSimp: A Flexible Missing Value Imputation Method to Support Regulatory Bioequivalence Assessment. Ann Biomed Eng. 2023 Jan; 51(1):163-173.
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. 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 Nov; 190:114526.
Zhang P, Feng K, Gong Y, Lee J, Lomonaco S, Zhao L. Usage of Compartmental Models in Predicting COVID-19 Outbreaks. AAPS J. 2022 Sep 02; 24(5):98.
Peck C, Campbell G, Yoo I, Feng K, Hu M, Zhao L. Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies. AAPS J. 2022 09 01; 24(5):97.
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. 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 Oct; 189:114519.
Gong X, Hu M, Liu J, Kim G, Xu J, McKee A, Palmby T, de Claro RA, Zhao L. Decoding kinase-adverse event associations for small molecule kinase inhibitors. Nat Commun. 2022 Jul 27; 13(1):4349.
Nallani SC, Li W, Calderon SN, Fields E, Roca RA, Xu Y, Zhao L, Fang L, Sahajwalla CG, Zineh I. Concentration-Response Model of Immediate Release Oxycodone Drug Liking by Different Routes of Abuse. Pain Med. 2022 Jul 01; 23(7):1311-1322.
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. 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.
Madabushi R, Seo P, Zhao L, Tegenge M, Zhu H. 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.
Sharan S, Choi S, Zou Y, Wang Y, Kim MJ, Fang L, Choi S, Makhlouf F, Grosser SC, Zhang X, Zhao L. Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System. AAPS J. 2022 May 02; 24(3):63.
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. Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches. CPT Pharmacometrics Syst Pharmacol. 2022 Jul; 11(7):833-842.
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Intern Med. 2022 Apr 01; 182(4):418-425.
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. Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products. Clin Pharmacol Ther. 2022 Nov; 112(5):982-989.
Wang Z, Ahluwalia SK, Newman B, Dhapare S, Zhao L, Luke MC. 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 Mar; 56(2):346-357.
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults. Endocrine. 2022 May; 76(2):349-358.
Möllenhoff K, Loingeville F, Bertrand J, Nguyen TT, Sharan S, Zhao L, Fang L, Sun G, Grosser S, Mentré F, Dette H. Efficient model-based bioequivalence testing. Biostatistics. 2022 Jan 13; 23(1):314-327.
Gong X, Hu M, Basu M, Zhao L. Heterogeneous treatment effect analysis based on machine-learning methodology. CPT Pharmacometrics Syst Pharmacol. 2021 Nov; 10(11):1433-1443.
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. Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary. CPT Pharmacometrics Syst Pharmacol. 2021 Nov; 10(11):1271-1275.
Zhao L, Li Z, Fang L, Kim MJ, Nallani SC, Sahajwalla CG, Calderon SN, Roca RA, Feng K, Zineh I, Lionberger R. 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.
Tsakalozou E, Alam K, Babiskin A, Zhao L. Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations. Clin Pharmacol Ther. 2022 May; 111(5):1036-1049.
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. Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial. JAMA. 2021 Jul 20; 326(3):240-249.
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. Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine. 2021 Dec; 74(3):592-602.
Raofi S, Kinjo M, Sun D, Li Z, Boyce H, Natarajan K, Frost M, Zhao L, Luke M, Lionberger R, Kelsh D, Kim MJ. Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users. Clin Transl Sci. 2021 Sep; 14(5):1977-1987.
Liang H, Zhao L, Gong X, Hu M, Wang H. Virtual screening FDA approved drugs against multiple targets of SARS-CoV-2. Clin Transl Sci. 2021 May; 14(3):1123-1132.
Wu F, Cristofoletti R, Zhao L, Rostami-Hodjegan A. 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.
Pawar G, Wu F, Zhao L, Fang L, Burckart GJ, Feng K, Mousa YM, Naumann F, Batchelor HK. Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products. AAPS J. 2021 Apr 21; 23(3):57.
Tsakalozou E, Babiskin A, Zhao L. 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 May; 10(5):399-411.
Fang L, Uppoor R, Xu M, Sharan S, Zhu H, Tampal N, Li B, Zhang L, Lionberger R, Zhao L. Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective. Clin Pharmacol Ther. 2021 Oct; 110(4):880-887.
Le Merdy M, Tan ML, Sun D, Ni Z, Lee SC, Babiskin A, Zhao L. 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.
Lee J, Gong Y, Bhoopathy S, DiLiberti CE, Hooker AC, Rostami-Hodjegan A, Schmidt S, Suarez-Sharp S, Lukacova V, Fang L, Zhao L. Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence. Clin Pharmacol Ther. 2021 Nov; 110(5):1190-1195.
Fang L, Sonvg X, Ji P, Wang Y, Maynard J, Yim S, Sahajwalla C, Xu M, Kim MJ, Zhao L. Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens. J Clin Pharmacol. 2020 Dec; 60 Suppl 2:S103-S109.
Sharan S, Wang Y, Donnelly M, Zou Y, Fang L, Kim MJ, Zhao L. Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States. J Clin Pharmacol. 2020 Dec; 60 Suppl 2:S34-S38.
Donnelly M, Tsakalozou E, Sharan S, Straubinger T, Bies R, Zhao L. 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 Dec; 60 Suppl 2:S26-S33.
Le Merdy M, Spires J, Lukacova V, Tan ML, Babiskin A, Xu X, Zhao L, Bolger MB. Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations. Pharm Res. 2020 Nov 19; 37(12):245.
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. Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype-Derived Activity Scores. CPT Pharmacometrics Syst Pharmacol. 2020 12; 9(12):678-685.
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. New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling. AAPS J. 2020 Oct 30; 22(6):141.
Lee J, Feng K, Xu M, Gong X, Sun W, Kim J, Zhang Z, Wang M, Fang L, Zhao L. Applications of Adaptive Designs in Generic Drug Development. Clin Pharmacol Ther. 2021 Jul; 110(1):32-35.
Miao L, Mousa YM, Zhao L, Raines K, Seo P, Wu F. Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations. AAPS J. 2020 Aug 10; 22(5):107.
Wittayanukorn S, Rosenberg M, Schick A, Hu M, Wang Z, Babiskin A, Lionberger R, Zhao L. Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions. Ther Innov Regul Sci. 2020 Nov; 54(6):1372-1381.
Yuan M, Li Y, Yang Y, Xu J, Tao F, Zhao L, Zhou H, Pinheiro J, Xu XS. A novel quantification of information for longitudinal data analyzed by mixed-effects modeling. Pharm Stat. 2020 Jul; 19(4):388-398.
Le Merdy M, Tan ML, Babiskin A, Zhao L. Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development. AAPS J. 2020 Jan 06; 22(2):26.
He H, Liu C, Liu Y, Liu X, Wu Y, Fan J, Zhao L, Cao Y. Mathematical modeling of the heterogeneous distributions of nanomedicines in solid tumors. Eur J Pharm Biopharm. 2019 Sep; 142:153-164.
Hu M, Babiskin A, Wittayanukorn S, Schick A, Rosenberg M, Gong X, Kim MJ, Zhang L, Lionberger R, Zhao L. Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology. Clin Pharmacol Ther. 2019 Jul; 106(1):174-181.
Bai JPF, Musante CJ, Petanceska S, Zhang L, Zhao L, Zhao P. American Society for Clinical Pharmacology and Therapeutics 2019 Annual Meeting Pre-Conferences. CPT Pharmacometrics Syst Pharmacol. 2019 Jun; 8(6):333-335.
Zhao L, Seo P, Lionberger R. Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products. CPT Pharmacometrics Syst Pharmacol. 2019 Jun; 8(6):347-351.
Walenga RL, Babiskin AH, Zhao L. In Silico Methods for Development of Generic Drug-Device Combination Orally Inhaled Drug Products. CPT Pharmacometrics Syst Pharmacol. 2019 Jun; 8(6):359-370.
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. 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 May 20; 21(4):65.
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. Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study. J Clin Pharmacol. 2019 Sep; 59(9):1266-1274.
Basu S, Yang H, Fang L, Gonzalez-Sales M, Zhao L, Trame MN, Lesko L, Schmidt S. Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products. J Clin Pharmacol. 2019 Sep; 59(9):1252-1263.
Kim H, Fang L, Yu J, Meng Z, Trame MN, Schmidt S, Lesko LJ, Zhao L. 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 Aug; 59(8):1061-1069.
Zhao L, Kim MJ, Zhang L, Lionberger R. Generating Model Integrated Evidence for Generic Drug Development and Assessment. Clin Pharmacol Ther. 2019 Feb; 105(2):338-349.
Jayachandran P, Okochi H, Frassetto LA, Park W, Fang L, Zhao L, Benet LZ. Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs. Clin Pharmacol Ther. 2019 02; 105(2):411-416.
Suggs CM, Levin RL, Mosholder AD, Swain RS, Zhao L. 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.
Yuan M, Xu XS, Yang Y, Xu J, Huang X, Tao F, Zhao L, Zhang L, Pinheiro J. 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 Dec; 28(12):3568-3578.
Walenga RL, Babiskin AH, Zhang X, Absar M, Zhao L, Lionberger RA. 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.
Hu M, Jiang X, Absar M, Choi S, Kozak D, Shen M, Weng YT, Zhao L, Lionberger R. Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance. AAPS J. 2018 Apr 12; 20(3):62.
Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L. Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop. Clin Pharmacol Ther. 2018 Jul; 104(1):27-30.
Gong X, Hu M, Zhao L. Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis. Clin Transl Sci. 2018 May; 11(3):305-311.
González-Sales M, Fang L, Kim MJ, Zhao L. 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.
Li Z, Fang L, Jiang W, Kim MJ, Zhao L. Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs. Curr Neurol Neurosci Rep. 2017 Sep 19; 17(11):82.
Fan J, Zhang X, Zhao L. 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 Sep; 19(5):1479-1486.
Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, Lukacova V, Eissing T, Tsakalozou E, Zhao L, Lionberger R. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop. CPT Pharmacometrics Syst Pharmacol. 2017 Aug; 6(8):492-495.
Ni Z, Talattof A, Fan J, Tsakalozou E, Sharan S, Sun D, Wen H, Zhao L, Zhang X. Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products. AAPS J. 2017 Jul; 19(4):1045-1053.
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. FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Clin Cancer Res. 2017 Oct 01; 23(19):5666-5670.
Sun D, Hu M, Browning M, Friedman RL, Jiang W, Zhao L, Wen H. Dissolution Failure of Solid Oral Drug Products in Field Alert Reports. J Pharm Sci. 2017 May; 106(5):1302-1309.
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. 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.
Zhao L, Au JL, Wientjes MG. Method to Assess Interactivity of Drugs with Nonparallel Concentration Effect Relationships. Curr Cancer Drug Targets. 2017; 17(8):735-755.
Chow EC, Talattof A, Tsakalozou E, Fan J, Zhao L, Zhang X. Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses. AAPS J. 2016 Nov; 18(6):1500-1511.
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. FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2015 Dec 01; 21(23):5205-8.
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. 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.
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. 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.
Zhou D, Li H, Wang Y, Hochhaus G, Sinha V, Zhao L. Quantitative characterization of circadian rhythm of pulmonary function in asthmatic patients treated with inhaled corticosteroids. J Pharmacokinet Pharmacodyn. 2015 Aug; 42(4):391-9.
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. FDA Approval Summary: Ramucirumab for Gastric Cancer. Clin Cancer Res. 2015 Aug 01; 21(15):3372-6.
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. FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease. Clin Cancer Res. 2015 Mar 01; 21(5):950-4.
Ma L, Zhao L, Xu Y, Yim S, Doddapaneni S, Sahajwalla CG, Wang Y, Ji P. Clinical endpoint sensitivity in rheumatoid arthritis: modeling and simulation. J Pharmacokinet Pharmacodyn. 2014 Oct; 41(5):537-43.
Zhao L, Ji P, Li Z, Roy P, Sahajwalla CG. 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, Shang EY, Sahajwalla CG. Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development. J Pharm Sci. 2012 Dec; 101(12):4367-82.
Zhao L, Ren TH, Wang DD. Clinical pharmacology considerations in biologics development. Acta Pharmacol Sin. 2012 Nov; 33(11):1339-47.
Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK. 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.
Zhao L, Li N, Yang H. 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, Au JL, Wientjes MG. Comparison of methods for evaluating drug-drug interaction. Front Biosci (Elite Ed). 2010 Jan 01; 2(1):241-9.
Zhao L. 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.
Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, Losonsky GA, Motavizumab Study Group. 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.
Zhao L, Wientjes MG, Au JL. 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.