Establishing the Proper Stability Shelf-Life Claim: A Case Study
The client was a small, virtual company. They had one person responsible for CMC activities. Their initial request was, "can you just take a look…
Stability Data Analysis Product Case Study
The client knew that they needed to conduct statistical-based stability analysis for their product. They had stability data for 25 lots of drug product…
Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A
In Pitfalls to Avoid For Determining a Product’s Shelf Life Q&A, The Windshire Group’s Chief Stability Scientist discusses Excel trending and the amount of time…