Population pharmacokinetics

Population pharmacokinetics

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Language(s):
English
Format:
Text
Subject(s):
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance is intended to assist sponsors and applicants2 of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and investigational new drugs (IND) applications in the application of population pharmacokinetic (PK) analysis. Population PK analysis is frequently used to guide drug3 development and inform recommendations on therapeutic individualization (e.g., through tailored dosing) (Marshall et al. 2015; Lee et al. 2011; Bhattaram et al. 2005). Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements or postmarketing commitments. This guidance includes common applications of population PK analysis to inform drug development and drug use. This list of applications is not meant to be comprehensive, but rather provides illustrative examples. This guidance also includes the FDA’s current thinking on the data and model submissions to support regulatory decisions, recommendations on how to incorporate information from population PK analyses in labeling, and the general expectations regarding the format and content for population PK reports submitted to the Agency. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (i, 24 pages)).
NLM Unique ID:
9918451286106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918451286106676