Preparation of drug submissions
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Preparation of drug submissions comparative bioavailability studies. by Canada. Therapeutic Products Directorate.

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Published by Therapeutic Products Directorate in Ottawa .
Written in English

Subjects:

  • Drugs -- Standards -- Canada.,
  • Drugs -- Canada.,
  • Pharmaceutical industry -- Canada -- Quality control.,
  • Pharmaceutical industry -- Canada -- Testing.

Book details:

Edition Notes

SeriesTherapeutic Products Directorate guidelines
Classifications
LC ClassificationsRS189 .P74 1997
The Physical Object
Paginationii, 31 p. ;
Number of Pages31
ID Numbers
Open LibraryOL18150058M
ISBN 100662260716

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Course Description - Course runs to both days (Breakfast & Lunch Included). This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions. Guidebook for Drug Regulatory Submissions is more than a useful guide―it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory by: 2. Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator 10/17/11 09/15/