Biotech & Biomedical/bioanalytical

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Expert: - 5/23/2008


Question
sir i would like to know howthecalculation is doing for a drug to be bioequivalent with other?and on which base the limit is fixed as 80-120% for a drug to be bioequivalent.what is meant by 90% confidential interval?

Answer
Hi, Simi,

To be "bioequivalent" two preparations or drugs need to give the same biological effect.

The usual "experimental error" put on this is 20% - thus, 80-120% is considered "bioequivalent".

90% confidence interval means that statistically it is 90% certain that the results are equivalent.

Hope this helps.

Best wishes,

Paul  

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Dr.Paul Skett

Expertise

drug metabolism or biotransformation from basic to advanced, hepatocytes from basic to advanced, drug toxicity and side effects, alcohol clearance and levels

Experience

32 years research experience in above areas, 30 years educational experience in University. Retained expert for numerous legal firms dealing with matters of drugs (legal and illegal)and alcohol.

Education/Credentials
B.Sc(Hons) Biochemistry, University of Liverpool, UK
fil.dr. (Medical Chemistry) Karolinska Institute, Stockholm, Sweden

Fellow of the British Pharmacological Society

Fellow of the Higher Education Academy

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