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
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.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
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.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
