S.I'M.ndall's Phone: - 2407 8300 - Fax: 91-022-24078879 Website: www.tdmlab.com E-mail: [email protected]PROTOCOL NUMBER: L (:i 080<1''2.5 - 0\ THERAPEUTIC DRUG MONITORING LABORATORY .. ~~~~-~-~ ---- -- •• - r INSTITUTIONAL ETHICS REVIEW COMMITIEE APPROVAL LETTER Date: '24 / R /2008. To THE THERAPEUTIC DRUG MONITORING LABORATORY 194,scheme No.6, Road No. 15, Sion-Koliwada, Sion (East), Mumbai - 400 022, INDIA Subject: A~ Approval to conduct G9mparati~ Bioavailability I Bioequivalence studies on Dear Sir, This is with reference to yoUr above-mentioned proposal to conduct BE studies on healthy human volunteers. The rremters of the Ethics Review Committee hereby approve the conduct of BE study on healthy human volunteers under the foUowing conditions: 1. The study will follow the normal protocol of two periods, two sequences, two treatments, randomized crossover design with necessary food and fluid control. 2, The maximum volume of blood withdrawn from each volunteer in a 24 HR. period will not exceed 150 mL 3. Validated Method will be used for the analysis. 4. This approval is valid for a period of six months from the date of approval by IRB or six months from the date of the protocol approval by the concerned drug regulating authorities, which ever is later. 5. Any change in the protocol must be done only with the consent of IRB. 6. The study should be conducted in ace a ce within the guidelines of ICMR and Helsinki. PAGE 001 OF 003 APPROVAL LETTER 296 W.~:s!t~~~t.:~ 194, Scheme No 6, Road No 15, Sion Koliwada, Sion (E), Mumbai 400 022 t •
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S.I'M.ndall's THERAPEUTIC DRUG ~~~~-~-~ …...Sion-Koliwada, Sion (East), Mumbai - 400 022, INDIA Subject: A·~ Approval to conduct G9mparati~ Bioavailability I Bioequivalence studies
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