Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects
To ensure that sponsors of new drug submissions have the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations with respect to comparative bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
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