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

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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.

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-- 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

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#bioequivalence #standardisation #samplingtime