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FDA Guidance - Pediatric Pharmacokinetic StudiesGuidance for IndustryGeneral Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Ln., rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Copies of this draft guidance are available from the Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, 5600 Fishers Lane, Rockville, MD 20857 (Phone 301-827-4573) or from the Internet at http://www.fda.gov/cder/guidance/index.htm. Copies also are available from the Office of Communication, Training and Manufacturers Assistance, HFM40, CBER, FDA, 1401 Rockville Pike, Rockville, MD 20852-1448, or from the Internet at http://www.fda.gov/cber/guidelines.htm. Copies also may be obtained by fax from 1-888-CBERFAX or 301-827-3844 or by mail from the Voice Information System at 800-835-4709 or 301-827-1800. For questions on the content of the draft document contact (CDER) Rosemary Roberts, 301-827-2120 or (CBER) Douglas Roberts, 301-827-5095. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 1998 CLIN X TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. STUDY DESIGN
IV. METHODOLOGY.
A. Standard Pharmacokinetic Study
B. Population Pharmacokinetic Study
C. Sample Collection
D. Sample Analysis
E. Covariates
F. Data Analysis
V. LABELING STATEMENTS
VI. ETHICAL CONSIDERATIONS
REFERENCES
GUIDANCE FOR INDUSTRY[1]
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