What are the guidelines for conducting bioequivalence studies?
This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally administered immediate-release (IR) 5 solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, 6 capsules, and granules/powders for oral suspension.
What is the CHMP & EMA guideline on bioequivalence based biowaivers?
Once finalised, the CHMP will implement it as a European guideline superseding the EMA Guideline on the investigation of bioequivalence for these oral dosage forms. Note Appendix III of the EMA guideline is already superseded by the ICH M9 Guideline on biopharmaceutics classification system-based biowaivers.
How many capsules / granules should be used for oral suspension?
6 capsules, and granules/powders for oral suspension. 8 justification is provided. Applicants are encouraged to consult the regulatory authority(ies) when 9 an alternate approach is proposed or taken. 13 pharmacokinetic (PK) BE studies or comparative in vitro dissolution studies. In addition to the
How many samples should be collected per phase?
This period is usually at least three times 272 the terminal half‐life of the drug, unless a suitable truncated AUC, e.g., AUC(0-72h), is used. To 273 permit calculation of the relevant PK parameters, a sufficient number of samples should be 274 collected per subject per period, distributed across all phases of disposition.
TD corrigés d’électromagnétisme
Projet Ř: Création de centres de bioéquivalence
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