confirmatory studies
- Guideline or reference source
- ICHQ1B Photostability testing of new drug substances and products
- Definition
- Confirmatory studies are those undertaken to establish photostability characteristics under standardized conditions. These studies are used to identify precautionary measures needed in manufacturing or formulation and whether light resistant packaging and/or special labeling is needed to mitigate exposure to light. For the confirmatory studies, the batch(es) should be selected according to batch selection for long-term and accelerated testings which is described in the Parent Guideline.
- Narrower Term
- confirmatory trial
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.