Dissolution Best Practices—Meeting Chinese Pharmacopeia Requirements
Date TBD
Virtual Event
Chinese pharmacopeia (CHP) has different requirements for dissolution testing compared to USP/Ph.Eur/JP. Some of these differences include testing approach and passing criteria differences and variation in interpretation of the “Q” for certain dosage forms. These differences can cause considerable retooling of methods and specifications, as a company plans to release product in China.
This workshop will provide:
- CHP rationale and requirements for dissolution
- Partnership with our global colleagues
- An opportunity to share preliminary AAPS survey findings on this issue and approaches to address and hear your feedback and concerns.
Patient-Centric Design of Long-acting Injectable Drug Products
March 9-10, 2022
Virtual Event
Long Acting Injectables (LAIs) are rapidly growing across the pharmaceutical industry for the treatment of chronic conditions (including infectious disease, mental health, and hormone treatments) as they offer the opportunity to reduce administration frequency, improve patience adherence and experience, and reduce healthcare costs. However, the path for design and development of LAIs is not as defined, as it is for other dosage forms (e.g., oral solid dosage forms). The ultimate target is to get the LAI drug product design and development space to the same level as the oral solid dosage forms, with clear regulatory guidelines (e.g., BCS classification, ICH M9), defined mechanistic understanding, predictive simulation tools (e.g., PBPK modeling) and biorelevant dissolution methods.
View the agenda and register now!
Drug Transporters in ADME: From the Bench to the Beside
April 11-13, 2022University of Maryland, College Park, MD
There are major challenges in the drug transporter field, and there is a need to learn from experts conducting cutting-edge research, as well as perspectives from regulatory agencies.
The overall goal of this workshop is to bring together experts in the transporter field from academia, industry, and regulatory agencies to enhance interaction and communication between these three entities. Participants will be exposed to cutting-edge transporter research and regulatory information improving their application of transporter information to drug discovery, development, and safety. Case studies have been incorporated throughout the program to enhance application knowledge in participants.