Innovative Early Development Regulatory Approaches: expIND, expCTA, Microdosing
Clinical Pharmacology & Therapeutics December 19, 2007 DOI: 10.1038/sj.clpt.6100461 via OpenAlex
Summary
AI-generated from the abstractRegulatory agencies like the FDA and European Medicines Agency seek more efficient drug development. One resulting initiative is the creation of guidance documents for exploratory investigational new drugs (INDs) and clinical trial applications (CTAs). This article reviews the history of those guidances and the industry's experience using them so far.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Citations | 37 |
| Key finding | The article reviews the history and industry experience of exploratory IND/CTA guidances as part of regulatory efforts to improve drug development efficiency. |
Abstract
The Food and Drug Administration (FDA) Critical Path Initiative as well as the European Medicines Agency Road Map to 2010 (ref. 2) call for opportunities for more efficient drug development. One of the initiatives that has emerged in this context is the elaboration through guidance of exploratory investigational new drugs (INDs)/clinical trial applications (CTAs). This article reviews the history of these emerging guidances as well as the experience to date in their use by the industry.