| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
/ read more /
| FORMULATION |
Adeline Siew
Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
/ read more /
| MANUFACTURING |
Jennifer Markarian
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
/ read more /
| ANALYTICS |
Jordan Collins, Naheed Sayeed-Desta, Ajay Pazhayattil, Chetan Doshi
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
/ read more /
| QUALITY |
Walt Murray, James Jardine
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
/ read more /
| PEER-REVIEWED RESEARCH |
Pramote Cholayudth
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
/ read more /
| EU REGULATORY WATCH |
Sean Milmo
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
/ read more /
| ASK THE EXPERT |
Susan J. Schniepp
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
/ read more /
|
