Transcription of DRAFT GUIDANCE ON APPROVAL OF CLINICAL …
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DRAFT GUIDANCE ON APPROVAL OF CLINICAL …
GUIDELINES ON APPROVAL OF CLINICAL TRIAL & new drugs Effective Date: Page 1 of 71 DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & new drugs DRAFT GUIDANCE This GUIDANCE document is for feedback purposes only. Comments suggestions, if any, may please be submitted to the office of Drugs Controller General India within thirty days latest by 24th August 2011. CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA JULY 2011 DOC # NDCT-20072011 GUIDELINES ON APPROVAL OF CLINICAL TRIAL & new drugs Effective Date: Page 2 of 71 1 ABBREVIATIONS AND DEFINITIONS API Active Pharmaceutical Ingredient BA Bio-availability BE Bio-equivalence CRF Case Record
guidelines on approval of clinical trial & new drugs effective date: page 1 of 71 draft guidance on approval of clinical trials & new drugs draft guidance
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