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Food and Drug Administration

Clinical Pharmacology Subcommittee
of the
Advisory Committee for Pharmaceutical Science

October 18-19, 2006

Briefing Information

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).  These redacted portions will appear as white space on the screen or on the printed page.

Executive Summary (pdf)

Novaldex Sample Label (pdf)

Guidance for Industry Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling (pdf)

Backgrounder by FDA Pharmacometrics (pdf)

Bibliography (pdf)

Additional References (pdf)

Page last updated October 16, 2006 kkhorizonal rule
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