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Updated: Jun 4, 2026

Establishment of a Clinic-based Biorepository
07:50

Establishment of a Clinic-based Biorepository

Published on: May 29, 2017

Establishing the Sri Lanka clinical trials registry

Udaya K Ranawaka1, Colvin Goonaratna

  • 1Sri Lanka Clinical Trials Registry and Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka. udayaran@yahoo.com

Journal of Evidence-Based Medicine
|February 26, 2011
PubMed

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Clinical Trials

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Clinical Trials: Overview

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Clinically Relevant Drug Product Specifications: Methods of Establishment

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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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Hazard Ratio

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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