Cover Image

Guidance for industry : nonclinical safety evaluation of pediatric drug products.

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006]
Subjects:	Drugs > United States > Testing. Pediatrics > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS120116

Similar Items

Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
Published: (2006)

Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.
Published: (1999)

Guidance for industry and review staff : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route.
Published: (2008)

Guidance for industry : how to comply with the Pediatric Research Equity Act.
Published: (2005)

Guidance for industry : M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals.
Published: (1997)

Pediatric drug research : Food and Drug Administration should more efficiently monitor inclusion of minority children.
Published: (2003)

Guidance for industry : Q1B photostability testing of new drug substances and products.
Published: (1996)

Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.
Published: (2005)

Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
Published: (2006)

Guidance for industry : stability testing, photostability testing of new veterinary drug substances and medicinal products.
Published: (1999)

Guidance for industry : photosafety testing.
Published: (2003)

Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2009)

Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Published: (1997)

Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
Published: (2003)

Guidance for industry : statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.
Published: (2001)

Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2007)

Guidance for industry : CGMP for phase 1 investigational drugs.
Published: (2008)

Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population.
Published: (2000)

Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.
Published: (2003)

Pediatric drug guide /
Published: (2005)

Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers.
Published: (2008)

The pediatric guide to drugs and vitamins /
by: Brace, Edward R.
Published: (1982)

Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation.
Published: (2000)

Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals.
Published: (2001)

Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Published: (1995)

Guidance for industry : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs).
Published: (2002)

Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
Published: (2005)

Guidance for industry : Q1E evaluation of stability data.
Published: (2004)

Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.
Published: (2004)

Evaluating the effectiveness of the Food and Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001.
Published: (2001)

Evaluating the effectiveness of the Food And Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001.
Published: (2001)

Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals.
Published: (1997)

Guidance for industry : studies to evaluate the safety of residues of veterinary drugs in human food, carcinogenicity testing.
Published: (2006)

Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Published: (2008)

Guidance for industry : handling and retention of BA and BE testing samples.
Published: (2004)

Marine employers drug testing guidance : (what marine employers need to know about drug testing) /
Published: (2005)

Guidance for industry : single dose acute toxicity testing for pharmaceuticals.
Published: (1996)

Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Published: (1995)

Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.
Published: (2008)

Guidance for industry : nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals.
Published: (2011)