NDA and ANDA
Understanding NDA and ANDA in the Pharmaceutical Industry The pharmaceutical industry is tightly regulated to ensure the safety, efficacy and quality of drugs. Two critical processes that facilitate the approval…
Safety and efficacy of the drug
Safety and Efficiency of Active Pharmaceutical Ingredients: A Critical Examination The active pharmaceutical ingredient (API) is the key component in any drug responsible for its therapeutic effects. Ensuring the safety…
Quality by Design
Quality by Design (QbD) in the Pharmaceutical Industry The pharmaceutical industry is governed by stringent regulatory requirements to ensure the safety, efficacy and quality of medicines. One transformative approach to…
Impurity profile-API
Types of Impurity Profiling of Drug Substances: Introduction: Impurity profiling is a critical aspect of pharmaceutical quality control that ensures the safety, efficacy and quality of drug substances and drug…