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…
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…
Transforming Healthcare Research: The Evolution of Ethical Standards
Introduction The Ethical Standards and practices in the pharmaceutical and healthcare domains have undergone significant…
From Idea to Impact: The Ultimate Guide to New Product Development
The drug development process is intricate and must ensure quality, safety, efficacy, and compliance, typically…