Historical
PDA TR 53-2011
Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
The objective of this Technical Report: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products is to describe and justify the studies using scientific data and rationale necessary to determine an appropriate stability budget for a drug product. This is the first of seven categories, or pillars, of Good Distribution Practices (GDPs).
CONTENT PROVIDER
Parenteral Drug Association [pda]
Parenteral Drug Association [pda]