How do we do design bioequivalence (BE) study? Standardisation & sampling time on BE guidelines 2022

Free notes in Wix: https://lighthousepharmaco.wixsite.co... An overview on two major aspects of the BE study design, namely standardisation of food, diet intake, fluid intake, medication intake, physical activity and sampling time design to ensure the success of bioequivalence study by obtaining good quality data. More frequent sampling time needs to be performed around the Cmax & Tmax with a maximum AUC at 72 hrs. All design aspects of bioequivalence studies need to be performed in accordance to the country-specific guidelines, in this case Malaysia/ASEAN. Most of the guideline concepts are similar between US FDA, EMA etc, with minor variation between different countries. The practical translation of guidelines into action of bioequivalence studies is also discussed in how to carry out the study based on guidelines requirement. For more BE or pharmacology-related videos, do visit the channel & stay tuned. 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 overall bioequivalence study design 8:17 - Standardisation: Diet, fluid, medication intake & practical points 24:31 - Variables in guidelines of different countries 30:44 - Sampling time: Blood taking, General generic medication, Endogenous substance, Urine sampling 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 –   / peiyuen_mednpharmaco   Telegram - https://t.me/lighthousepharmaco #bioequivalence #standardisation #samplingtime