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In Silico Clinical Trials for Cardiovascular Disease
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In Silico Clinical Trials for Cardiovascular Disease

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Gateways to clinical trials

A Tomillero1, M A Moral

  • 1Thomson Reuters, Barcelona, Spain. scientific.prousjournals@thomsonreuters.com

Methods and Findings in Experimental and Clinical Pharmacology
|January 13, 2011
PubMed

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Preclinical Development: Overview

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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