Last Updated on October 22, 2024
Bio-Equivalence and Bio-Availability (BE/BA) Studies
Bioequivalence studies are conducted to evaluate the difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
Following Bio Availability and Bio Equivalence Studies are carried out with the approval of Clinical Studies Committee:-
| S.No | BA/BE Study Registration no. | Title of BA/BE Study | Licence No. of BA/BE Studies Center | Address of BA/BE Center | Date of issuance of BA/BE Study approval | Duration of BA/BE Study. |
|---|---|---|---|---|---|---|
| 1 | BA/BE-0001 | A Single Center, Open Label, Randomized, Single Dose, Two way Cross-over study to explore the Bioequivalence of Lamnet (Lamotrigine) l00mg tablet with the reference product Lamictal (Lamotrigine) l00mg tablet under fasting condition in healthy Pakistani male subjects. | BA/BE-C-0002 | Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, | Approved. Dated 28th August 2020. | 21 Days |
| 2 | BA/BE-0002 | A Single Center, Open Label, Randomized, Single Dose, Two way cross-over study to explore the Bioequivalence Xaroban (Rivaroxaben) 20mg Tablet with reference product Xarelto (Rivaroxaben) 20mg Tablet under the fed conditions in Healthy Male Pakistani Subjects. | BA/BE-C -0002 | Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, | Approved. Dated 28th August 2020. | 11 Days |
| 3 | BA/BE-0003 | A Single Center, Open Label, Randomized, Single Dose, Two Period, Two way Cross-over Study to explore the Bioequivalence Vaptor (Rosuvastatin) 20mg Tablet and Crestor (Rosuvastatin) 20mg Tablet under the fasting conditions in Healthy Male Pakistani Subjects. | BA/BE-C-0002 | Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, | Approved. Dated 28th August 2020. | 12 Days |
| 4 | BA/BE-0004 | A Single Center, Open Label, Randomized, Single Dose, Two-way Cross-over Study to explore the Bioequivalence of ANPLAG (Ticagrelor) 90mg Tablets (M/s Pharm Evo (Pvt) Ltd.) with the reference product Brilinta 90 mg Tablet (M/s Astra Zeneca Pharmaceuticals, USA) under fasting conditions in healthy male Pakistani subjects | BA/BE-C-0002 | Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, | Approved. Dated 28th August 2020. | 12 Days |
| 5 | BA/BE-0005 | A Single-Center, Open-Label, Randomized, Single-Dose, two-way Cross-over Study to compare the rate & extent of absorption of Mofest® (Moxifloxacin) 400mg Tablet of M/s Sami Pharmaceuticals (Pvt) Ltd with Avelox® (Moxifloxacin) 500mg Tablet of M/s Bayer Pakistan, in healthy Pakistani subjects. | BA/BE-C-0002 | Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, | Approved. Dated 29th April 2022. | 30 Days |