Impurities: Classification, Thresholds, and specification with RTR Considerations
The content discusses the importance of maintaining drug quality through managing impurities and degradation products…
ICH: Driving Global Harmonization in Regulatory Standards
ICH: Overview and Structure The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for…
Clinical Studies in Drug Development: Ensuring Safety and Approval
Introduction Clinical studies are an essential component of the drug development process, playing a critical…
Stability Data Requirements for New Product Applications: A Master Guide
Pharmaceutical products must maintain quality, safety, and efficacy throughout their lifecycle, influenced by environmental factors…