Dear Fellow, Pharmaceutical Scientists.
I am pleased to invite you all to the Bioequivalence and Bioavailability Sciences community webinar on September 10, 2024. Please plan on attending this interesting webinar by following the link given below and I request each one of you to circulate this announcement among your peer groups and interested colleagues.
Topic: Applications of bio-predictive dissolution methodologies and dissolution similarity approaches in generic drug product development
· Speakers: Siva Charan Kollipara, M. Pharm. and Tausif Ahmed, Ph.D.
· Abstract: Dissolution is a critical attribute that can impact the in vivo behavior of dosage forms. Dissolution is not only used as a quality control tool but can also be used to assess the in vivo performance of the dosage forms. Over the past few years, dissolution has gained significant importance from manufacturing and clinical quality perspectives. While QC dissolution is used to ensure the batch-to-batch consistency and for release of drug product, bio predictive dissolution can be used to predict the in vivo behavior of dosage forms. This webinar is aimed to discuss the recent trends in bio predictive dissolution methodologies to predict bioequivalence of generic drug products. Use of bio predictive dissolution data as an input into physiologically based modeling approaches will be described. Along with this, novel dissolution similarity assessment approaches such as bias corrected and accelerated f2 bootstrap approach and multivariate statistical distance will be discussed for successful establishment of dissolution similarity. Overall, this webinar aims to visit the current state of art on dissolution approaches for successful bio prediction and biowaivers.
Siva Charan Kollipara, M.S, *Pharm. Team Lead, Biopharmaceutics., Dr Reddy's Laboratories Ltd.
Mr. Sivacharan Kollipara is a Team Lead, Biopharmaceutics in the Global Clinical Management group, IPDO at Dr. Reddy's Laboratories Limited (DRL), Hyderabad. He is responsible for biopharmaceutics evaluation, bioequivalence risk assessment, and bioequivalence prediction for conventional as well as complex generic products at DRL. He is also involved in PK modeling and simulations activities supporting generic drug development of various immediate release, modified release, and complex products at DRL and involved in utilizing novel PBPK and PBBM modeling approaches for regulatory justifications for various markets. Prior to joining DRL, Mr. Kollipara was Principal Scientist (Global Pharmaceutical Development) at Novartis Healthcare Pvt Ltd., Hyderabad. Previously he also has been associated with Ranbaxy Research Laboratories, Gurgaon (Metabolism and Pharmacokinetics). He obtained M. Pharm. from BITS, Pilani, Rajasthan, India and currently pursuing Ph.D. Overall Mr. Kollipara has an experience of 16 years in the field of drug discovery, development and generic product development, bioanalytical method development and validation, PK data modelling and simulations. He has authored/co-authored ~35 peer-reviewed publications. His research interests include PBPK/PBBM modeling, virtual bioequivalence simulations, IVIVC/R, drug-drug interactions, dissolution/bioequivalence safe space, bio-predictive dissolution methodologies, biowaivers, novel statistical tools for dissolution similarity analysis and food effect evaluations.
Tausif Ahmed, PhD , VP & Head – Biopharm. & BE Global Clinical Management., Dr. Reddy's Laboratories Ltd.
Dr. Tausif Ahmed is a Vice President & Head-Biopharmaceutics & Bioequivalence in the Global Clinical Management group, IPDO at Dr. Reddy's Laboratories Limited (DRL), Hyderabad. He is responsible for managing all BE studies supporting global CGRx products at DRL. He is also involved in PK/Modelling and Simulation activities supporting global generic development. Prior to joining DRL, he was Associate Director and Head-DMPK (preclinical discovery, Clinical dev., and Generic) & Dy. Test Facility Mgt. GLP toxicology dept. at Piramal Enterprises Limited, Mumbai. Dr. Ahmed has been associated with different pharmaceutical companies such as Dr. Reddy's Research Foundation (DRF), Ranbaxy Research Laboratories, Sai Life Sciences Limited, and Piramal Enterprises Limited in the past. He obtained MS in Pharmaceutics from NIPER and PhD in Pharmaceutical Medicine (specialization: Biopharmaceutics and PK/PD) from Hamdard University (Ranbaxy, now Sun Pharma Sponsored). He has been working in the field of drug discovery, development, phase I/II, and generic BA-BE studies for more than 23 years. His area of specialization includes DMPK, metabolite-ID, population PK, PK-PD modelling, and simulation, generic BA/BE studies and GLP bioanalysis. In recent years his focus is on use PBBM/PBPK modelling in generic drug development. He has extensive experience in outsourcing preclinical and clinical studies to CROs both in and outside of India. Dr. Ahmed has contributed to >15 IND filings, multiple ANDAs, and Phase I/II/III regulatory submissions, nationally and globally. He has co-authored two book chapters and over 50 papers and presentations. He is a reviewer for many international journals and is on the Editorial board of Int. J. Pharma Research. Dr. Ahmed is a guest faculty at Hamdard University, NMIMS (Mumbai), NIPER, and various other universities in India. He has also supervised many Master's and PhD students.
Mark your Colanders and join the webinar on September 10, 2024 , using information given below.
AAPS September 2024 BEBAS Community Webinar
Sep 10, 2024, 11:00 AM – 12:30 PM (USA- EST - New York)
Please join this meeting from your computer, tablet or smartphone.
https://meet.goto.com/162295837
You can also dial in using your phone.
Access Code: 162-295-837
United States: +1 (224) 501-3412
Join from a video-conferencing room or system.
Meeting ID:162-295-837
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Or dial directly: [email protected] or 67.217.95.2##162295837
Get the app now and be ready when your first meeting starts:
https://meet.goto.com/install
------------------------------
Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
East Windsor NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------