How do we design bioequivalence study for generic drug? Washout, Characteristics & Strength 2022

Описание: Free notes in wix: https://lighthousepharmaco.wixsite.co...

Generic drugs must undergo bioequivalence study to be registered in the market. In this video, we’ll go through the sections on washout period, characteristics & strength to be investigated as explained in the EMA 2010 & ASEAN 2015 guidelines. Different categories of drugs eg the standard design, alternative design, multiple dose, endogenous substance, bracket approach, linear pharmacokinetics & non-linear pharmacokinetics, fixed combinations.

Criteria of biowaiver for different strength is also discussed. % weight of excipients & active ingredients to be calculated. Characteristics of Cmax, Tmax & AUC 72 hours are also discussed.

Other bioequivalence related videos can also be found in my channel on introduction of overall concept & sampling time can also be viewed here.

If you like the content & would want more videos on BE study design, do comment +1 at the comment section.

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-- Content --
0:00 - Intro on overview on 3 main categories of bioequivalence study design & guidelines, ie immediate release, modified release & orodispersible
3:06 - Washout period: Standard, alternative design & endogenous substance
9:30 - Characteristics to be investigated: Cmax, Tmax, AUC: Parent compound, metabolites
17:43 - Enantiomers, urinary data & endogenous substance
24:25 - Strength to be investigated: Biowaiver criteria, linear, non-linear pharmacokinetics, bracketing approach & fixed combination
38:31 - Modified release & orodispersible tablets

WHO AM I: Hi! I’m Dr Yuen, a pharmacist @ pharmacology lecturer in a pharmacy school. I’m reorganising my lectures for my students, hopefully it’ll be useful for you too in your revision.

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