Evaluation of effects of tableting variables on drug stability: a case study with gabapentin
- At: 2011 FIP Congress in Hyderabad (India)
- Type: Presentation
- By: KHAN, Mansoor (FDA, Rockville, United States of America)
Drug product stability is often provided by sponsors at accelerated conditions of temperature and humidity to obtain a tentative expiration date at ambient conditions. It works very well for most solid oral products. This expiration date based on predictions is then backed by stability at ambient conditions. In some cases, though, the.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.