Inactive Ingredient Database (IID) – A Predictive Tool for Product Development
Inactive Ingredient: An inactive ingredient is a component of a dosage form, other than the active ingredient, which is inert material and enhances the drug…
Drug Development Process – Stages in Product Lifecycle
The Lifecycle of a Drug (Pharmakon) or Biologic is initiated to address a disease or an ailment for which there is unmet clinical need or…
OBJECTIVE DRUG SUBSTANCE DRUG PRODUCT 2.1.1. General Stability of the drug substance is an integral part of the systematic approach to stability evaluation…
Changes to Approved NDA or NDA
REPORTING CATEGORIES A major change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or…