Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe
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Faronoh Attarchi, PhD, RAC Director. Affairs. Global Quintiles Regulatory Inc.
Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe
Key Words Exploratory I N D : Screening I N D ; Microdose; Critical path initiative; Supporting toxicology behavior
Correspondence Address Faraneh Attarchi. PhD. RAC, Director. Regulatory Affairs. America. Global Regulatory Affairs. Quintiles Inc., 6700 West 115 St., Overland. Park, KS 66211 (e-mail: faraneh.attarchi @quintiles.com).
IN T R O D U C T l O N In contrast to a traditional Investigational New Drug Application (IND), under which typically only one molecule can be investigated, an Exploratory IND provides a sponsor the opportunity to conduct early-stage clinical studies on a series of closely related molecules under the same IND. This provision therefore enables sponsors to select the most promising molecule from a series of closely related molecules for further development using human subjects. This is beneficial because human subjects are the most reliable models for development of pharmaceutical products intended for human use. A further advantage offered by an Exploratory IND is a lowered requirement for supporting toxicology data. This reduction in required supporting toxicology data is a result of the limits set for exposure of human subjects to the test molecule in studies permitted under an Exploratory IND. Because the exposure limitation minimizes the risk to the subjects, fewer data are required to ensure their safety. This reduction in required toxicology data is also useful in making a "goho-go" decision on further development of a single molecule under a traditional IND. This is because it enables a sponsor to obtain a more reliable picture of the pharmacological potential of a molecule by testing it in human subjects by taking advantage of sufficiency of an abbreviated supporting toxicology package.
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In contrast to a traditional Investigational New Drug Application (I"), under which tupicalk only one mdecule can be investigated, an Exploratory IND provides a sponsor the opportunity to conduct early-stage clinical studies on a series of closely related mdecules under the same IND. This provision, therefwe, enables sponsors to select the most promising mdecule, fiom a series of closely related mdecules, forfirther development using human subjects. This article provides an overview of the advantages and limitations of this approach to drug devdopment.
It may be helpful to know that the early-stage clinical studies permitted under an Exploratory IND are sometimes referred to as phase 0 or prephase I studies. The aim of this article is to provide: An overview of the Food and Drug Administration's (FDA's) Draft Guidance for Exploratory IND studies with the goal of bringing this excellent guidance to the attention of those who have not yet come across it. A discussion of the limitations on subject exposure to the test molecule in these early-stage studies. A brief discussion of a similar provision in Europ
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