extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life threatening conditions
By: [developed by an ICH Expert Working Group].
Contributors: Canada. Health Protection Branch.; International Conference on Harmonisation.
Series: Drugs Directorate guidelines; ICH harmonised tripartite guideline
Publisher: Health Protection Branch, Health and Welfare Canada
Published: 1995
Place of publication: Ottawa, Ont
Language: eng
Subjects: Drugs -- Safety measures.; Drugs -- Standards.; Drugs -- Testing.
Notes: Issued also in French under title: Degré d'exposition de la population et évaluation de l'innocuité des médicaments destinés au traitement à long terme d'états ne menaçant pas la vie.

"International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use."

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