PRACTICUM 5: BIOVAILABILITY AND STUDY BIOEQUIVALENCE Description of Theory The quality of every product that will be circulated on the market must be guaranteed so that by using the product the desired therapeutic effect will be achieved. Generic or "me too" products that will be marketed are also inseparable from these requirements. A generic or “me too” product must meet the same standards as the innovator product in terms of quality, efficacy and safety. Apart from evaluationin vitro, bioequivalence evaluationin vivo It is also necessary to ensure that the bioavailability of generic or “me too” products does not differ significantly (statistically insignificant)of a comparison product. In general, those used as comparison products are innovator products that first obtain approval from the authorized party to be marketed. Obtaining bioequivalent status for a product is expected to produce the same effect and safety response as the comparison product. This will give doctors and patients the opportunity to choose various drug brands with the guarantee that each product will provide comparable clinical effects and safety.Bioequivalence testing becomes very important when the patent period for an innovator product expires. Apart from that, bioequivalence tests are also carried out during the development period of a product, there is a change in manufacturing method or location, there is a change in manufacturing equipment, or there is a change in the source of the raw materials used.The pharmacokinetic parameters used to evaluate the bioequivalence status of a product are: - AUC (area the curve of concentration-tome relationship,area under the curve of the relationship between concentration and time) - Cmax(maximum concentration) - Tmax(time to reach maximum concentration) In practice, the Cmax and Tmax values are obtained from the maximum concentration measured by the concentration in the sample obtained and the time when the maximum concentration is reached. It should be noted in determining Tmax that in the peak area of the curve the relationship between concentration and time profile of the curve is relatively flat so that due to variability in the assay method used, the Tmax value obtained may not be the actual Tmax. Things that need to be considered in bioequivalence research so that the results obtained can be used include: - Subjects, which includes determining inclusion and exclusion criteria when selecting research subjects, initial treatment that needs to be carried out on subjects before the bioequivalence test is carried out. - Design, including how many subjects will be used, gender, and research design. - The treatment that will be given, which includes the dose of drug used, method of administration, sampling plan such as what sample will be collected (blood, plasma or urine) and time of sample collection. - Evaluation of the results obtained, including the statistical tests that will be used and determining the definition of bioequivalence before the test begins. Implementation of Practicum a. Tools and materials Materials: Semilog paper, worksheet Tools: Scientific calculator b. Work procedures 1) Each group gets data on bioavailability parameters from test sample questions and innovators. 2) Each group carries out the task of calculating the bioavailability value of bioequivalents based on the data provided and analyzing the data obtained. 3) Conclude the bioequivalence status of the test product given to the innovator.