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24 Pharmaceutical Technology ® Trends in Formulation 2023 eBook PharmTech.com • m in im izing t he number of pi lot PK st udies required • providing more confidence in the outcome of piv- otal BE studies • developing complex generics. References 1. FDA. PDUFA Reauthorization Performance Goals and Procedures for Fiscal Years 2018 Through 2022. FDA.gov (accessed April 20, 2017). 2. FDA. Dra f t Guida nce, T he Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceu- t ics A pplicat ions for Oral D r ug P roduct De velop- ment, Manufacturing Changes, and Controls. Octo- ber 2020. 3. Wu, F; Shah, H.; Li, M.; et al. Biopharmaceutics Applications of Physiologically Based Pharmaco- kinetic Absorption Modeling and Simulation in Regulatory Submissions to the US Food and Drug Administration for New Drugs. AAPS J. 2021 23 (2) 31. DOI: 10.1208/s12248-021-00564-2. 4. Mukherjee, D.; Chiney, M.S.; Shao, X.; et al. Physi- ologically Based Pharmacokinetic Modeling and Simulations to Inform Dissolution Specifications and Clinical Relevance of Release Rates on Elagolix Exposure. Biopharm. Drug Dispos. 2022 43 (3) 98–107. DOI: 10.1002/bdd.2315. 5. Mukherjee, D.; Chen, M.-J.; Shao, X.; et al. Virtual Bioequivalence Assessment of Elagolix Formula- tions Using Physiologically Based Pharmacokinetic Modeling. A A PS J. 2023 25 (3) 30. DOI: 10.1208/ s12248-023-00794-6. 6. Amore, B.M.; Patel, N.; Batheja, P.; et al. Physiolog- ically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Be- mpedoic Acid Oral Suspension and Reference Tablet Formulation. Pharmaceutics 2023 15 (5) 1476. DOI: 10.3390/pharmaceutics15051476. ■ Drug De velopment A Big Impact: Trends Shaping Small- Molecule APIs, Excipients, and Formulations In this episode of the Drug Digest video series, key industry experts focus on small-molecule APIs, excipients, and formulation advances, including a discussion about novel approaches and solutions to pediatric formulations and taste-masking, a rundown of the fundamental stages of gaining a certificate of suitability for APIs, and a deliberation on the biggest trends impacting the industry and key sessions to visit while at CPHI. Drug Digest is a tech talk video series with the Pharmaceutical Technology ® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. David Tisi Director of Technical Operations, Synopsys Tara Fitzpatrick Head of Quality, C 2 Pharma Bikash Chatterjee President and Chief Science Officer at PharmaTech Associates Tara Dougal Content Director—Pharma, Informa Markets Sean K. Daughtry Director of Technical Operations Analytical, CMSC Strategic Product Lead—AMKD, Vertex Pharmaceuticals Ramesh Subramanian Chief Commercial Officer, Aragen Life Sciences For more videos, visit PharmTech.com!