Frequently Asked Question: Dissolution testing
Dissolution testing of pharmaceutical drug products is one of the most important tools during drug development and for quality assurance during quality control (QC) release testing. This testing is mandatory for all oral solid dose, oral semi solid dose, and oral suspension products. It is not required for drugs that are already in solution such […]
From R&D to Quality Control (QC): Developing QC-Friendly Analytical Methods
Quality control is an integral part of the drug development process, and the quality of analysis can make a difference in a drug product’s safety and efficacy. QC-friendly analytical methods are simple to operate and require minimum sample preparation. They are robust, reliable, and efficient for routine analytical tests. Furthermore, the analytical tests run by […]
Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development
Drug development is a complex and highly regulated process that necessitates ongoing validation to ensure drug product safety and efficacy. A phase appropriate method validation technique is applied at each step of drug development; with flexibility being provided in the initial stages where the methods can change. As the phases advance toward clinical use, strict […]