Dharmi Trivedi
Professional Pharmaceutical Quality and Compliance Specialist, USA
Title: Stability considerations from early stage development through phase-IV of pharmaceutical drug products
Biography
Biography: Dharmi Trivedi
Abstract
Stability studies are key components of pharmaceutical drug products during early stage development through phase-IV that supports in establishing the drug product re-test date and shelf life by evaluating the data generated under controlled environmental storage conditions. Real time data is an ongoing stability in the drug development process while the clinical trial is ongoing and during late stage of development process. Drug manufacturer must assure that product remains stable during the course of clinical trials in early development process and it remains stable during the shelf life in late development stages and during post marketing until it reaches to the expiration date. To meet this obligation, manufacturer makes commitments to the regulatory authorities during ANDA/NDA submission. This paper describes the stability considerations of pharmaceutical drug products for early stage development (pre-clinical and Phase-1 and Phase-2), ICH stability studies to support NDA application in Phase-3 and monitoring ongoing stability and stability due to post approval changes in Phase-IV, of pharmaceutical drug product cycle.