Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther. 2011;89(2):259–67.
Article CAS PubMed Google Scholar
Zhang X, Yang Y, Grimstein M, Fan J, Grillo JA, Huang SM, et al. Application of PBPK modeling and simulation for regulatory decision making and its impact on US prescribing information: an update on the 2018–2019 submissions to the US FDA’s Office of Clinical Pharmacology. J Clin Pharmacol. 2020;60(Suppl 1):S160–78.
Wagner C, Zhao P, Pan Y, Hsu V, Grillo J, Huang SM, et al. Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK. CPT Pharmacometrics Syst Pharmacol. 2015;4(4):226–30.
Article CAS PubMed PubMed Central Google Scholar
Yoon M, Babiskin A, Hu M, Wu F, Raney SG, Fang L, et al. Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery. CPT Pharmacometrics Syst Pharmacol. 2023;12(5):552–5.
Lin W, Chen Y, Unadkat JD, Zhang X, Wu D, Heimbach T. Applications, challenges, and outlook for PBPK modeling and simulation: a regulatory, industrial and academic perspective. Pharm Res. 2022;39(8):1701–31.
Article CAS PubMed Google Scholar
Maharaj AR, Edginton AN. Physiologically based pharmacokinetic modeling and simulation in pediatric drug development. CPT Pharmacometrics Syst Pharmacol. 2014;3(11): e150.
Article CAS PubMed Google Scholar
Anand O. Clinically relevant dissolution specifications: a biopharmaceutics’ risk based approach: an FDA perspective. The Academy of Pharmaceutical Sciences. Webinar Series. May 18, 2021. [Available from: https://www.apsgb.co.uk/wp-content/uploads/2021/05/Clinically-Relevant-Dissolution-Specifications-an-FDA-Perspective-__Om-Anand.pdf. Accessed 24 Jul 2023.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, et al. Applications of physiologically based biopharmaceutics modeling (PBBM) to support drug product quality: a workshop summary report. J Pharm Sci. 2021;110(2):594–609.
Article CAS PubMed Google Scholar
Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, et al. Mechanistic oral absorption modeling and simulation for formulation development and bioequivalence evaluation: report of an FDA public workshop. CPT Pharmacometrics Syst Pharmacol. 2017;6(8):492–5.
Article CAS PubMed PubMed Central Google Scholar
Al Shoyaib A, Riedmaier AE, Kumar A, Roy P, Parrott NJ, Fang L, et al. Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: a workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023;12(5):610–8.
The use of physiologically based pharmacokinetic analyses — biopharmaceutics applications for oral drug product development, manufacturing changes, and controls. Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER) October 2020 Pharmaceutical Quality/CMC [Available from: https://www.fda.gov/media/142500/download. Accessed 24 Jul 2023.
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;10(5):399–411.
Article CAS PubMed PubMed Central Google Scholar
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;8(6):347–51.
Article CAS PubMed PubMed Central Google Scholar
Le Merdy M, Tan ML, Babiskin A, Zhao L. Physiologically based pharmacokinetic model to support ophthalmic suspension product development. AAPS J. 2020;22(2):26.
Babiskin A, Wu F, Mousa Y, Tan ML, Tsakalozou E, Walenga RL, et al. Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: a workshop overview. CPT Pharmacometrics Syst Pharmacol. 2023;12(5):619–23.
Lee J, Gong Y, Bhoopathy S, DiLiberti CE, Hooker AC, Rostami-Hodjegan A, et al. Public workshop summary report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: data analysis and model-based bioequivalence. Clin Pharmacol Ther. 2021;110(5):1190–5.
Wang Y, Zhu H, Madabushi R, Liu Q, Huang SM, Zineh I. Model-informed drug development: current US regulatory practice and future considerations. Clin Pharmacol Ther. 2019;105(4):899–911.
Suarez-Sharp S, Li M, Duan J, Shah H, Seo P. Regulatory experience with in vivo in vitro correlations (IVIVC) in new drug applications. AAPS J. 2016;18(6):1379–90.
Article CAS PubMed Google Scholar
Yuvaneshwari K, Kollipara S, Ahmed T, Chachad S. Applications of PBPK/PBBM modeling in generic product development: an industry perspective. Journal of Drug Delivery Science and Technology. 2022;69: 103152.
Wu F, Shah H, Li M, Duan P, Zhao P, Suarez S, et al. Biopharmaceutics applications of physiologically based pharmacokinetic absorption modeling and simulation in regulatory submissions to the U.S. Food and Drug Administration for new drugs. AAPS J. 2021;23(2):31.
Heimbach T, Kesisoglou F, Novakovic J, Tistaert C, Mueller-Zsigmondy M, Kollipara S, et al. Establishing the bioequivalence safe space for immediate-release oral dosage forms using physiologically based biopharmaceutics modeling (PBBM): case studies. J Pharm Sci. 2021;110(12):3896–906.
Article CAS PubMed Google Scholar
Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, et al. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link-a workshop summary report. AAPS J. 2019;21(2):29.
Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T. Physiologically based pharmacokinetics modeling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharm Res. 2023;40(2):337–57.
Article CAS PubMed Google Scholar
Laisney M, Heimbach T, Mueller-Zsigmondy M, Blumenstein L, Costa R, Ji Y. Physiologically based biopharmaceutics modeling to demonstrate virtual bioequivalence and bioequivalence safe-space for ribociclib which has permeation rate-controlled absorption. J Pharm Sci. 2022;111(1):274–84.
Article CAS PubMed Google Scholar
Wu D, Li M. Current state and challenges of physiologically based biopharmaceutics modeling (PBBM) in oral drug product development. Pharm Res. 2023;40(2):321–36.
Article CAS PubMed Google Scholar
Kesisoglou F, Vertzoni M, Reppas C. Physiologically based absorption modeling of salts of weak bases based on data in hypochlorhydric and achlorhydric biorelevant media. AAPS PharmSciTech. 2018;19(7):2851–8.
Article CAS PubMed Google Scholar
O’Shea JP, Holm R, O’Driscoll CM, Griffin BT. Food for thought: formulating away the food effect - a PEARRL review. J Pharm Pharmacol. 2019;71(4):510–35.
Jankovsky C, Tsinman O, Thakral NK. Food effect risk assessment in preformulation stage using material sparing muFLUX methodology. ADMET DMPK. 2022;10(4):299–314.
PubMed PubMed Central Google Scholar
Zhang G, Wang C, Wu L, Xu J, Hu X, Shakya S, et al. Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability. Sci Rep. 2018;8(1):12765.
Article PubMed PubMed Central Google Scholar
Fadda HM, Hellstrom PM, Webb DL. Intra- and inter-subject variability in gastric pH following a low-fat, low-calorie meal. Int J Pharm. 2022;625: 122069.
Article CAS PubMed Google Scholar
Parrott N, Stillhart C, Lindenberg M, Wagner B, Kowalski K, Guerini E, et al. Physiologically based absorption modelling to explore the impact of food and gastric pH changes on the pharmacokinetics of entrectinib. AAPS J. 2020;22(4):78.
Article CAS PubMed Google Scholar
Koziolek M, Alcaro S, Augustijns P, Basit AW, Grimm M, Hens B, et al. The mechanisms of pharmacokinetic food-drug interactions - a perspective from the UNGAP group. Eur J Pharm Sci. 2019;134:31–59.
Article CAS PubMed Google Scholar
Braeckmans M, Augustijns P, Mols R, Servais C, Brouwers J. Investigating the mechanisms behind the positive food effect of abiraterone acetate: in vitro and rat in situ studies. Pharmaceutics. 2022;14(5):952.
Yasuji T, Kondo H, Sako K. The effect of food on the oral bioavailability of drugs: a review of current developments and pharmaceutical technologies for pharmacokinetic control. Ther Deliv. 2012;3(1):81–90.
Article CAS PubMed Google Scholar
Gataric B, Parojcic J. An investigation into the factors governing drug absorption and food effect prediction based on data mining methodology. AAPS J. 2019;22(1):11.
Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, et al. Applications of clinically relevant dissolution testing: workshop summary report. AAPS J. 2018;20(6):93.
McAllister M, Flanagan T, Boon K, Pepin X, Tistaert C, Jamei M, et al. Developing clinically relevant dissolution specifications for oral drug products-industrial and regulatory perspectives. Pharmaceutics. 2019;12(1):19.
Mohamed MF, Winzenborg I, Othman AA, Marroum P. Utility of Modeling and simulation approach to support the clinical relevance of dissolution specifications: a case study from upadacitinib development. AAPS J. 2022;24(2):39.
Article CAS PubMed Google Scholar
Mohamed MF, Trueman S, Othman AA, Han JH, Ju TR, Marroum P. Development of in vitro-in vivo correlation for upadacitinib extended-release tablet formulation. AAPS J. 2019;21(6):108.
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, et al. Exposure-response analyses of upadacitinib efficacy and safety in phase II and III studies to support benefit-risk assessment in rheumatoid arthritis. Clin Pharmacol Ther. 2020;107(4):994–1003.
Article CAS PubMed Google Scholar
Clarke JF, Thakur K, Polak S. A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products. Front Pharmacol. 2022;13:1007496.
Article CAS PubMed PubMed Central Google Scholar
Patel N, Clarke JF, Salem F, Abdulla T, Martins F, Arora S, et al. Multi-phase
Comments (0)