Regulatory Framework: NDA vs. ANDA New Drug Application (NDA) An NDA is a comprehensive...
Introduction to In Vivo Testing Bioavailability Study Definition: Bioavailability studies...
Introduction to Stability Studies The development of stability data is a critical component in the tablet formulation and design process....
What is Process Validation? FDA Definition: The FDA Guidelines on General Principles of...
What is Granulation? Definition: Granulation may be defined as a size enlargement process which...
The Quality Strength "Quality cannot be tested into products; it has to be built in by design" -...
Active Pharmaceutical Ingredients (APIs) Two Broad Classes of APIs in Tablets: ...
Course Outline: ...
1. Introduction to Liquid Chromatography What is Liquid Chromatography? Liquid chromatography is a separation technique that involves: ...
Introduction to Pharmaceutics "At its simplest – pharmaceutics converts a drug into a medicine." Introduction Pharmaceutics is the discipline of pharmacy...