EMA Seeks Public Consult on Bioequivalence Concept Paper
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
The European Medicines Agency has released its draft concept paper on the development of product-specific guidance on demonstration of bioequivalence. Public comments are open until September 30.
EMA plans to develop product-specific guidance to enable a consistent approach to the assessment of applications based on bioequivalence data across various submission routes to help companies design study programs that meet European Union regulations. The guidance will be based on EMA’s guideline on the investigation of bioequivalence.
Source:
European Medicines Agency
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
