biopharmceutics notes from maam galagar

2
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

Upload: dunerafael

Post on 26-May-2015

461 views

Category:

Documents


2 download

DESCRIPTION

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

TRANSCRIPT

Page 1: Biopharmceutics Notes  from Maam Galagar

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 substitution2. purpose of bioavailability studies

Group 2:1. discuss relative & absolute bioavailability2. methods of assessing bioavailability3. bases for determining bioavailability

Group 3:1. criteria for establishing a bioequivalence requirement2. criteria for waiver of evidence of in vivo bioavailability3. design & evaluation of bioequivalence studies

Group 4:1. clinical significance of bioequivalency studies2. 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