Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products
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This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is [i.e.], new drug and abbreviated new drug submissions) of changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
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Notice: Policy on Bioequivalence Standards for Highly Variable Drug ProductsHTMLEnglish publication HTML
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Notice: Policy on Bioequivalence Standards for Highly Variable Drug ProductsHTMLFrench publication HTML