stability study drug substance
- Definition
- The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a re-test period applicable to all future batches of the drug substance manufactured under similar circumstances. The degree of variability of individual batches affects the confidence that a future
- Related Term
- stability commitment
Send comments to info@celegence.com Please read disclaimer before using Qsauri.