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

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. Please Like and Subscribe to my channel and click the bell icon to get new video updates. Thank you! -- 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. GET IN TOUCH: Instagram –   / lighthousepharmacology_med   Facebook -   / 378848233592032   Tiktok - @dryuen_explains Telegram - https://t.me/lighthousepharmaco #bioequivalencestudy #washoutperiod #genericdrugcharacteristicsnstrength