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Health Canada Addendum to ICH Guidance Document E11: Clinical Investigation of Medicinal Products in the Pediatric Population
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Document Date: 2013-11-18 10:37:07

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File Size: 56,98 KB

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City

Ottawa / /

Country

Canada / /

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Facility

Publications Brooke Claxton Building / /

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IndustryTerm

treatment of specific newborn or congenital metabolic disorders / important patient / physico-chemical and biologic properties / biological therapeutic products / health products / effector systems / medicinal product / therapeutic product / similar products / chemical / medicinal products / food / /

MedicalCondition

concomitant illness / disease / congenital metabolic disorders / Treat Other Diseases / diseases / Life-Threatening Diseases / inflammation / /

MedicalTreatment

gene therapy / biological therapies / /

Organization

Health Products and Food Branch / Senior Medical Advisor Bureau / Therapeutic Products Directorate / Biologics and Genetic Therapies Directorate / Submission Management Division Centre for Policy / /

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Position

coordinator / Minister of Health / representative / Minister of Public Works / /

ProvinceOrState

Ontario / /

Technology

gene therapy / pharmacokinetics / Biotechnology / transplantation / drug development / /

URL

http /

SocialTag