Drugs Directorate guidelines =
Subtitle: Directives de la Direction des médicaments.
Contributors: Canada. Health Protection Branch.
Publisher: Health Protection Branch, Health and Welfare Canada = Direction générale de la protection de la santé, Santé et bien-être social Canada
Published: 1989
Place of publication: [Ottawa]
Language: eng
Subjects: Drugs -- Law and legislation -- Canada -- Handbooks, manuals, etc.; Biological products -- Law and legislation -- Canada -- Handbooks, manuals, etc.
Other titles: Directives de la Direction des médicaments.; Good manufacturing practices.
Notes: Text in English and French.

Looseleaf for updating.

Cop. 1 lacks chapter: Labelling of drugs for human use.
Table of contents: title: Good manufacturing practices; title: Labelling of drugs for human use; title: Product monographs; title: Conduct of clinical investigations; title: Glossary of terms; title: Completing an application for registration as a proprietary medicine; title: Homeopathic preparations, application for drug identification numbers; title: Consumer drug advertising; title: Toxicologic evaluation; title: Disinfectants, preparation of application for drug identification number; title: Manufacture and testing of monoclonal antibodies and their conjugates; title: Utilization of continuous cell lines in the manufacture of biologics; title: Manufacture and testing of biologics produced by recombinant DNA technology; title: Traditional herbal medicines; title: Chemistry and manufacturing: new drugs; title: Preparation of human new drug submissions; title: Preparation of investigational new drug submissions; title: Preparation of veterinary new drug submissions; title: Inspection of biologics manufacturers; title: Guide for the labelling of drugs for veterinary use; title: Labelling of cosmetics; title: Blood collection and blood component manufacturing; title: Conduct and analysis of bioavailability and bioequivalence studies, pt. A.; title: Dose-response information to support drug registration; title: Stability testing of new drug substances and products; title: Studies in support of special populations : geriatrics; title: Product master files; title: Disinfectant drugs; title: Directions for use of estrogen-progestin combination oral contraceptives (OCs); title: Guidelines for reporting adverse reactions to marketed drugs; title: Structure and content of clinical study reports; title: Impurities in new drug substances; title: Extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions; title: Clinical safety data management: definitions and standards for expedited reporting