[e-drug] Study of stability of medicines under tropical conditions (4)

["Karim Smine" <lahrizi65@hotmail.com>]

E-DRUG: Study of stability of medicines under tropical conditions (4)
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Dear Paul,
 
In addition to What Dr. Atemnkeng recommended, I suggest you also consider the following:

- What are your stability indicating tests ?
- If the drug you want to test has a monograph, this should give you a good idea about how many units you will need.
- Please refer also to pharmacopeias (e.g. General chapter <1150> Pharmaceutical stability of USP-31, 2008 p.613)
- Another good source of information is the manufacturer of the product or the regulatory authority of the country where that product is registered and where you want to carry the study. Information about stability of drugs are required to obtain Market Authorization.Good Luck with your study,
 
Best regards,
 
Karim Smine, Ph.D.
Head of Drug Regulation
Health Authority - Abu Dhabi
United Arab Emirates
E-mail: lahrizi65@hotmail.com