Biopharmceutics Notes from Maam Galagar

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This is from Maam Galagar. Thank you Ellaine Yeo for sharing this with me!

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Biopharmceutics Notes from Maam Galagar

  1. 1. Topic: Bioavailability & Bioequivalence Group 1: 1. Define the following terms: a. bioavailability b. bioequivalence c. bioequivalent drug products d. brand name e. chemical name f. drug product g. drug product selection h. generic name i. generic substitution j. pharmaceutic alternatives k. pharmaceutic equivalents l. pharmaceutic substitution m. therapeutic alternatives n. therapeutic equivalents o. therapeutic substitution 2. purpose of bioavailability studies Group 2: 1. discuss relative & absolute bioavailability 2. methods of assessing bioavailability 3. bases for determining bioavailability Group 3: 1. criteria for establishing a bioequivalence requirement 2. criteria for waiver of evidence of in vivo bioavailability 3. design & evaluation of bioequivalence studies Group 4: 1. clinical significance of bioequivalency studies 2. special concerns in bioavailability and bioequivalence studies The same grouping we had last meeting. We will start the reporting on tuesday, after the quiz. If you have any questions, just text me. Tnx! email me for confirmation. Margel Camille Luy-Galagar, RPh

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