Development And Biopharmaceutics Of Long-Acting Injectables
PQRI BTC/DTC Webinar SeriesDevelopment and Biopharmaceutics ofLong-Acting InjectablesModerators:Ajit Narang, Ph.D., GenentechDiane Paskiet, West Pharmaceutical ServicesPresenters:Liang Zhao, Ph.D., US Food and Drug AdministrationViera Lukacova, Ph.D., Simulations Plus, Inc.April 2021
AgendaI. Welcome and Overview of WebinarModerators:Ajit Narang, Ph.D., GenentechDiane Paskiet, West Pharmaceutical ServicesII. Application of Quantitative Clinical Pharmacology in the Development of LongActing Injectable (LAI) Drug ProductsPresenter:Liang Zhao, Ph.D., US FDAIII. Physiologically Based Pharmacokinetic (PBPK) Modeling of Long ActingInjectables (LAI): Challenges and OpportunitiesPresenter:Viera Lukacova, Ph.D., Simulations Plus, Inc.IV. Moderated Q&A Session with the speakersPQRI WebinarApril 20212
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Product Quality Research Institute (PQRI)Mission:PQRI is a non-profit consortium of organizations working together to generate andshare timely, relevant, and impactful information that advances drug productquality, manufacturing, and regulation.PQRI WebinarApril 20214
What Does PQRI Do ? Unites thought leaders from regulatory agencies, standard settingbodies, industry and academia to conduct research and shareknowledge on emerging scientific and regulatory quality challenges Provides a unique, neutral forum to develop broad consensus among adiverse collection of industry organizations and regulatory bodies Creates opportunities to accomplish mutual goals that cannot beachieved by individual organizations Impacts global regulatory guidance and standards, bringing maximumvalue to members and patientsPQRI WebinarApril 20215
PQRI Structure PQRI consists of two governing bodies – a Board of Directors and Steering Committee andthree Technical Committees, Technical Committees each have a broad disciplinary focus that collectively spans the drugproduct regulatory lifecycle. They establish and provide scientific guidance, direction andoversight to PQRI working groups and research projects. Current PQRI Technical Committees: Biopharmaceutics Technical Committee (BTC) Development Technical Committee (DTC) Product Quality Technical Committee (PQTC) This webinar is co-sponsored by the BTC and DTC. You can find out more information about the TCs onthe PQRI website: https://pqri.org/about-pqri/PQRI WebinarApril echnicalCommitteeProduct QualityTechnicalCommittee6
PQRI WebinarsPosted at https://www.gotostage.com/channel/pqriwebinars2021 Webinars BTC/DTC Development and Biopharmaceutics of Long-Acting Injectables (April 8, 2021) Presenters:Liang Zhao, Ph.D., US FDA and Viera Lukacova, Ph.D., Simulations Plus, Inc.2020 Webinars Biopharmaceutics of mAbs: Fundamentals and Pharmaceutical Development Aspects (December 9, 2020) Regulatory Requirements and Scientific Considerations for Biosimilar Products (September 16, 2020) Presenters: Presenters: Mikolaj Milewski, Ph.D. and Jingtao Zhang, Ph.D., Merck & Co., Inc.Stacey Ricci, M.Eng., Sc.D, FDA; Leah Christl, Amgen; Sundar Ramanan, Ph.D., MBA, BioConBTC/PQTC Webinar Series: Excipient Considerations for Parenteral Drug Development (July 29, 2020) Presenters:Janeen Skutnik-Wilkinson (Biogen) and Thomas Tice, Ph.D., EvonikThe Challenge and the Promise: Developing Complex Drug Products (April 28, 2020) Presenters: Wenlei Jiang, Ph.D.,FDA and Adrian Goodey, Ph.D., Merck2019 Webinars The Expanding IVIVC Toolbox to Enable Drug Product Quality and Clinical Pharmacology – ComplementaryTraditional and PBPK Based Approaches (June 7, 2019) Presenters: Xianyuan (Susie) Zhang, Ph.D., FDA and FilipposKesisoglou, Ph.D., Merck Holistic QbD to Enable Product Quality Webinar (October 10, 2019) Presenters: Ajit Narang, Ph.D., Genentech; RakhiShah, Ph.D., FDA; Xavier Pepin, Pharm.D, Ph.D; Divyakant Desai, Ph.D., BMS; Xavier Pepin, Pharm.D, Ph.D., AstraZenecaPQRI WebinarApril 20217
Conference Tracks Day #1 Focus:Biopharmaceutics Day #2 Focus:Development Day #3 Focus: ProductQuality Poster Session andNetworking5th PQRI/FDA Conference onAdvancing Product Quality:Advancing Quality & Technologyof Future PharmaceuticalsSave the Dates:December 1 – 3, 2021More information to be posted on the PQRIwebsite: www.pqri.org.100% Virtual Event8
Today’s PresentersLiang Zhao, Ph.D., Director, Director of Division of Quantitative Methods and ModelingOffice of Research and Standards (ORS)/Office of Generic Drugs (OGD)/CDER/ US Food and DrugAdministrationLiang.Zhao@fda.hhs.govDr. Liang Zhao is currently the Director of Division of Quantitative Methods and Modeling (DQMM), Office ofResearch and Standards, Office of Generic Drugs, CDER/FDA. Dr. Zhao has a broad spectrum of scientific andmanagement experience from industry and the regulatory agency. Through his 16-year professional career, hehas established his leadership in industrial R&D, quantitative methods and modeling, and model basedstrategic decision makings in regulatory and industrial settings for generic and new drugs.Dr. Liang Zhao has been serving as Director of DQMM since 2015. He initially joined the FDA as a clinicalpharmacology reviewer in the Office of Clinical Pharmacology in 2009 and worked as a team leader in theDivision of Pharmacometrics in 2013-2015. Prior to joining FDA, he worked at Medimmune for biotechproducts, BMS for small molecule drug development, and Pharsight as an associate consultant for new drugR&D. Dr. Zhao has authored and coauthored 80 peer reviewed articles and book chapters, and has been aseasoned speaker in FDA workshops, major national and international conferences.PQRI WebinarApril 20219
Today’s PresentersViera Lukacova, Ph.D., Chief ScientistSimulations Plus, Inc.viera@simulations-plus.comDr. Lukacova is Chief Scientist at Simulations Plus, Inc. Over the last decade she hasbeen contributing to the research in the area of mechanistic absorption and PBPKmodeling and the development of GastroPlus , DDDPlus , and MembranePlus software packages widely used throughout the pharmaceutical industry in early drugdevelopment, formulation, pre-clinical, and clinical research. She also contributes tomodeling studies helping companies with their drug development programs in theearly discovery stage, formulation development, clinical pharmacology applicationsand interactions with regulatory agencies.PQRI WebinarApril 202110
Thank you for attending the webinar!For more information on PQRI, visit our website at:www.pqri.orgQuestions? Contact the PQRI Secretariat at:PQRISecretariat@pqri.orgCall for VolunteersIf you or your company is a member of a PQRImember organization (CHPA, FDA, Health Canada,IPEC-Americas, PDA or USP) and you would like toparticipate in any of the PQRI Technical Committees,please contact the PQRI Secretariat(PQRISecretariat@pqri.org) for further information.PQRI WebinarApril 202111
Simulations Plus, Inc. viera@simulations-plus.com Dr. Lukacova is Chief Scientist at Simulations Plus, Inc. Over the last decade she has been contributing to the research in the area of mechanistic absorption and PBPK modeling and th
I. INTRODUCTION TO BIOPHARMACEUTICS and PHARMACOKINETICS - Chapter 1.-INTRODUCTION. Concepts and relevance of biopharmaceutics and pharmacokinetics. Sources of information. The passage of drugs through the body. The LADME process: Overview and basic concepts of drug release, absorption, distribution, metabolism and excretion. Chapter 2.-
biopharmaceutics in the simplest possible language and easy to understand style for the students. The textbook keeps the balance between the basic essentials and advanced areas of knowledge, apart from the usual topics. The distinguishing features of the book are succinct summary of
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Applied Biopharmaceutics and Pharmacokinetics; 7th edition, Leon Shargel and Andrew B.C. Yu McGraw-Hill 978-0071830935 Pharmacokinetics and Metabolism in Drug Design, 3rd edition, Dennis A. Smith, R. Manholder, Wiley & John Wiley 978-3527329540 Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications Fourth Edition,
is a classical textbook and comprises relevant current informations expanded and treated in an unique style . Essentials of Biopharmaceutics and Pharmacokinetes (2010), Chemistry of Natural Products Vol 1 . (2009), Pharmacognosy and Pharmacobiotechnology (2nd edn, 2009), Advanced Practical Medicinal Chemistry (2nd edn, 2015), Pharmaceutical .
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