Safety efforts in pediatric drug development / Conor D. Byrne, editor.

Format:

Book

Contributor:

Byrne, Conor D.

Series:

Pharmacology-research, safety testing, and regulation series.

Pharmacology--research, safety testing and regulation series

Language:

English

Subjects (All):

United States. Best Pharmaceuticals for Children Act.

United States.

Pediatric pharmacology--United States.

Pediatric pharmacology.

Pediatrics--United States--Formulae, receipts, prescriptions--Safety measures.

Pediatrics.

Drug development--United States--Safety measures.

Drug development.

Physical Description:

1 online resource (149 p.)

Edition:

1st ed.

Place of Publication:

New York : Nova Science Publishers, c2010.

Language Note:

English

Summary:

This work focuses on the safety efforts being implemented in paediatric drug development. It also evaluates the impact of Best Pharmaceuticals for Children Act (BPCA) on labelling drugs for paediatric use and the process by which the labelling was changed, and illustrates the range of diseases treated by the drugs studied under BPCA.

Contents:

FDA's authority to ensure that drugs prescribed to children are safe and effective / Susan Thaul

Guidance for industry nonclinical safety evaluation of pediatric drug products / U.S. Dept. of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER)

Pediatric drug research : studies conducted under Best Pharmaceuticals for Children Act / GAO

Pediatric drug research : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act / GAO.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record; title from PDF title page, viewed (07/20/2020).

ISBN:

1-61209-368-X

OCLC:

699510130