Introduction:

Before a Drug or Drug product is marketed it has to be subjected to stability studies by placing it in real-time stability under conditions that simulate real-world storage conditions of a product in its storage container. This test is time consuming and expensive. Hence accelerated stability technique was devised during the product development stage that will enable rapid prediction of the long term stability of a product within short period of time.

Accelerated Stability Testing: Studies designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing programme. The data thus obtained, in addition to those derived from real-time stability studies, may be used to assess longer-term chemical effects under non-accelerated conditions and to evaluate the impact of short-term excursions outside the label storage conditions, as might occur during shipping.

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Reference Readings:

Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability d... Read More >

Analytical StudiesThe woman who may be induced by the title of this book to open it, can save herself the trouble; she has already read the work without knowing it. A man, however malicious he may possibly be, can never say about a woman as much good or as much evil as they themselves think.

Searle lands 10-item 483 for shoddy stability, validation studies.(Human Drugs): An article from: Inspection MonitorThis digital document is an article from Inspection Monitor, published by Washington Information Source on March 1, 2004. The length of the article is... Read More >

Temporal stability of the timeline followback interview for alcohol and drug use with psychiatric outpatients *.: An article from: Journal of Studies on AlcoholThis digital document is an article from Journal of Studies on Alcohol, published by Alcohol Research Documentation, Inc. on November 1, 2004. The len... Read More >

Protocols for stability and homogeneity studies of drugs for its application to doping control [An article from: Analytica Chimica Acta]This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in 2004. The article is delivered in HTML format and is ... Read More >