Pharmacokinetics and Pharmacodynamics (PK/PD) Studies in Drug Development: From ADME Principles to Translational Applications
Understanding how a drug behaves in the body and how it exerts its therapeutic effects is essential for...
Pharma Quality Control Strategies for Drug Development and Regulatory Compliance
In pharmaceutical development, ensuring that products consistently meet predefined standards of identity, strength, purity, and quality it’s essential....
Preclinical Research in Drug Development: From Toxicology to Translational Insights
Before a new compound can be administered to humans, it must undergo a rigorous process to ensure its...
ICH Guidelines for Analytical Method Validation: Principles, Requirements and Industry Applications
In pharmaceutical development, validating analytical methods goes further than regulatory formality. It is a critical component of ensuring...
ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development
Impurities in pharmaceuticals can compromise the safety, efficacy, and stability of a product. To safeguard public health, global...
Analytical Priorities in Drug Development: How Preclinical Data Shapes Regulatory Success
The preclinical research phase in the drug development process involves the extensive evaluation of candidate compounds before clinical...
Quality Control in Biotechnology: Ensuring Safety in the Biologics Manufacturing Process
The use of biologics has grown exponentially in the last decade, driven by advances in genetic engineering, a...
ICH Q3E Guideline: Impurities Assessment and Control
The safety and efficacy of pharmaceutical products largely depend on controlling impurities in their formulations. Therefore, the International...