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Hi
To all
I want to know about how to decide washout period and timepoints in
the bioequivalence study
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Dear Prashant,
the Wash out period is directly calculated from the biological half
life of the drug. Usually for drugs with high clearance 5 halflives
are sufficient and those with low 9 to 11 are taken. If you refer
Applied Biopharmaceutics and Pharmacokinetics, they tell it as 7
halflives to be appropriate for most cases but Clinics on a
precautionary measure follow 9-11 as the count.
Regarding the the time point selection, there are various factors
influencing its selection. Type of dosage form (IR/CR/ER etc), The
absorption characterstics of the drug + site of application, and to
mention they are numerous. there is an article in Journal of
Pharmaceutical Sciences regarding the time point selection (1965 -
1978 issues). I suggest you refer pubmed for the same.
Hope this helps
Santosh Tata
Bioanalytical Division, BEC
Apotex Inc, Bangalore
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