Related Experiment Video
Updated: Apr 13, 2026

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
Published on: July 14, 2023
Genesis of Changes to Legislation and Guidelines that Regulate Clinical Trials
1Clinical Trials Consultant, Fieldhead, Troutbeck, Penrith, CA110SH, UK. drbriandavis@btinternet.com.
Abstract:
The genesis of changes to legislation and guidelines that regulate the development and licensing of medicines is complex and involves discussion and negotiation among a large number of people with different aims, interests and starting points. Those proposing a change to the way clinical trials are conducted need therefore to promote their proposal within the groups established for bringing forward changes to the guidance and legislation by participation in or responding to consultations. This paper reviews established European Union, United Kingdom and International procedures that would have to be used to introduce changes to clinical trials guidelines and legislation.
Related Concept Videos
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Preclinical Development: Overview
Drug Regulation
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Clinically Relevant Drug Product Specifications: Methods of Establishment

