Additionally, in some regions details from the ICH guidelines have been either written into, or are referred to in, local regulations [4,5].It is therefore usually considered ‘safer’ to conservatively follow the guidelines along the paths mapped out.
The next stage is to perform accelerated stability testing for excipient compatibility studies during formulation development and to support assignment of initial shelf lives/storage conditions for early toxicological and clinical studies.
Long-term stability studies will also be initiated on both the active pharmaceutical ingredient (API) and the drug product, generally following many of the principles contained in the ICH stability guidelines, with storage at accelerated and long-term conditions.
Unless the expectations outlined in ICH guideline Q1A(R2) have been met as part of the clinical stability program, registration stability studies are traditionally performed before filing a Common Technical Document (CTD).
Do drugs really stop working after the date stamped on the bottle?
Sitting on a $1 billion stockpile of drugs and facing the daunting process of destroying and replacing its supply every two to three years, the military began a testing program to see if it could extend the life of its inventory.
Introduction From a pharmaceutical development point of view, stability studies are frequently on the critical path to starting patient studies and registration stability studies, as described in the International Conference on Harmonisation (ICH) guideline Q1A (R2), are commonly the activity on the critical path to regulatory filing and approval .
Stability studies are also a significant resource commitment in both pre and post-approval phases.
This article examines the decisions to be made regarding the design of a stability strategy during development and some alternative approaches, compared to those traditionally followed, are proposed as being more scientifically rigorous.
Following these approaches would lead to better product understanding and robustness as well as to a reduction in the number of scientifically redundant stability studies.