Pioglitazone Tablet Dissolution and IVIVC Profile
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One of the great challenges in the inception of pharmaceutical research in the area of correlating in vitro drug release data of various drug formulations to the in vivo drug profiles (IVIVC).The main objective of developing and evaluating an IVIVC is to reduce the number of bioequivalence studies performed during the initial approval process as well as with certain scale-up and post approval changes. IVIVC development could lead to improved product quality and decreased regulatory burden. It is imperative that the drug pioglitazone under consideration is now one of the more widely used drugs ...
One of the great challenges in the inception of pharmaceutical research in the area of correlating in vitro drug release data of various drug formulations to the in vivo drug profiles (IVIVC).The main objective of developing and evaluating an IVIVC is to reduce the number of bioequivalence studies performed during the initial approval process as well as with certain scale-up and post approval changes. IVIVC development could lead to improved product quality and decreased regulatory burden. It is imperative that the drug pioglitazone under consideration is now one of the more widely used drugs for treatment of Type 2 diabetes mellitus. Therefore, for the welfare of humanity it is very necessary to generate information in our population to develop our own therapeutic standards under local environment. This study will meet the concept and application of the in vitro-in vivo correlation (IVIVC) for a pharmaceutical dosage form pioglitazone a main focus of attention of pharmaceutical industry, academia and regulatory sectors.
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