Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

References

• Bhattiprolu AK, Kollipara S, Ahmed T, Boddu R, Chachad S. 2022. Utility of physiologically based biopharmaceutics modeling (PBBM) in regulatory perspective: application to Supersede f2, enabling biowaivers & creation of dissolution safe space. J Pharm Sci. 111(12):3397–3410. doi: 10.1016/j.xphs.2022.09.003.
   PubMed Web of Science ®Google Scholar
• Declaration of Helsinki 1964. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June and amended by the WMA General Assembly, Seoul, Korea, October 2008. https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf. Accessed 10th Jun 2023.
   Google Scholar
• Dodd S, Kollipara S, Sanchez-Felix M, Kim K, Meng Q, Beato S, Heimbach T. 2019. Prediction of ARA/PPI drug-drug interactions at the drug discovery and development interface. J Pharm Sci. 108(1):87–101. doi: 10.1016/j.xphs.2018.10.032.
   PubMed Web of Science ®Google Scholar
• EMA, Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation 2019. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-simulation_en.pdf. Accessed 10th Jun 2023.
   Google Scholar
• Good Clinical Practices for Clinical Research in India 2013. Central drugs standard control organization. Ministry of Health and Family Welfare, Government of India. https://rgcb.res.in/documents/Good-Clinical-Practice-Guideline.pdf. Accessed 10th Jun 2023.
   Google Scholar
• Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, Sjögren E, Tsakalozou E, Seo P, Li M, et al. 2019. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link—a workshop summary report. AAPS J. 21(2)29. doi: 10.1208/s12248-019-0298-x.
   PubMed Web of Science ®Google Scholar
• Indian Council of Medical Research 2017. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. https://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf. Accessed 10th Jun 2023.
   Google Scholar
• Jaiswal S, Ahmed T, Kollipara S, Bhargava M, Chachad S. 2021. Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets. Drug Dev Ind Pharm. 47(5):778–789. doi: 10.1080/03639045.2021.1934870.
   PubMed Web of Science ®Google Scholar
• Karlgren M, Ahlin G, Bergström CA, Svensson R, Palm J, Artursson P. 2012. In vitro and in silico strategies to identify OATP1B1 inhibitors and predict clinical drug-drug interactions. Pharm Res. 29(2):411–426. doi: 10.1007/s11095-011-0564-9.
   PubMed Web of Science ®Google Scholar
• Kollipara S, Ahmed T, Bhattiprolu AK, Chachad S. 2021. In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: comparison among various regulatory agencies. Biopharm Drug Dispos. 42(7):297–318. doi: 10.1002/bdd.2292.
   PubMed Web of Science ®Google Scholar
• Kollipara S, Bhattiprolu AK, Boddu R, Ahmed T, Chachad S. 2023. Best practices for integration of dissolution data into physiologically based biopharmaceutics models (PBBM): a biopharmaceutics modeling scientist perspective. AAPS PharmSciTech. 24(2):59. doi: 10.1208/s12249-023-02521-y.
   PubMed Web of Science ®Google Scholar
• Loisios-Konstantinidis I, Cristofoletti R, Fotaki N, Turner DB, Dressman J. 2020. Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: naproxen. Eur J Pharm Sci. 143:105170. doi: 10.1016/j.ejps.2019.105170.
   PubMed Web of Science ®Google Scholar
• Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, et al. 2021. Applications of physiologically based biopharmaceutics modeling (pbbm) to support drug product quality: a workshop summary report. J Pharm Sci. 110(2):594–609. doi: 10.1016/j.xphs.2020.10.059.
   PubMed Web of Science ®Google Scholar
• Nakagomi-Hagihara R, Nakai D, Tokui T, Abe T, Ikeda T. 2007. Gemfibrozil and its glucuronide inhibit the hepatic uptake of pravastatin mediated by OATP1B1. Xenobiotica. 37(5):474–486. doi: 10.1080/00498250701278442.
   PubMed Web of Science ®Google Scholar
• Takano R, Furumoto K, Shiraki K, Takata N, Hayashi Y, Aso Y, Yamashita S. 2008. Rate-limiting steps of oral absorption for poorly water-soluble drugs in dogs; prediction from a miniscale dissolution test and a physiologically-based computer simulation. Pharm Res. 25(10):2334–2344. doi: 10.1007/s11095-008-9637-9.
   PubMed Web of Science ®Google Scholar
• Vijaywargi G, Kollipara S, Ahmed T, Chachad S. 2023. Predicting transporter mediated drug-drug interactions via static and dynamic physiologically based pharmacokinetic modeling: a comprehensive insight on where we are now and the way forward. Biopharm Drug Dispos. 44(3):195–220. doi: 10.1002/bdd.2339.
   PubMed Web of Science ®Google Scholar
• Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T. 2023. Physiologically based pharmacokinetics modeling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharm Res. 40(2):337–357. doi: 10.1007/s11095-022-03319-6.
   PubMed Web of Science ®Google Scholar
• Wu F, Shah H, Li M, Duan P, Zhao P, Suarez S, Raines K, Zhao Y, Wang M, Lin H-p, et al. 2021. 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. 23(2):31. doi: 10.1208/s12248-021-00564-2.
   Web of Science ®Google Scholar
• Yeo KR, Walsky RL, Jamei M, Rostami-Hodjegan A, Tucker GT. 2011. Prediction of time-dependent CYP3A4 drug-drug interactions by physiologically based pharmacokinetic modelling: impact of inactivation parameters and enzyme turnover. Eur J Pharm Sci. 43(3):160–173. doi: 10.1016/j.ejps.2011.04.008.
   PubMed Web of Science ®Google Scholar
• Yuvaneshwari K, Sivacharan K, Ahmed T, Chachad S. 2022. Applications of PBPK/PBBM modeling in generic product development: an industry perspective. J Drug Deliv Sci Technol. 69:103152. doi: 10.1016/j.jddst.2022.103152.
   Web of Science ®Google Scholar
• Zhao P, Lee CA, Kunze KL. 2007. Sequential metabolism is responsible for diltiazem-induced time-dependent loss of CYP3A. Drug Metab Dispos. 35(5):704–712. doi: 10.1124/dmd.106.013847.
   PubMed Web of Science ®Google Scholar
• Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, et al. 2011. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther. 89(2):259–267. doi: 10.1038/clpt.2010.298.
   PubMed Web of Science ®Google Scholar
• Zhuang X, Lu C. 2016. PBPK modeling and simulation in drug research and development. Acta Pharm Sin B. 6(5):430–440. doi: 10.1016/j.apsb.2016.04.004.
   PubMed Web of Science ®Google Scholar