Biosimilars production in Africa opportunities & challenges-Reference-Cited by-同舟云学术

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Biosimilars production in Africa opportunities & challenges

Published:2024-05 Issue: Volume:149 Page:105626
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Abdel-Maged Amany E.,Mikhaeil Margrit F.,Elkordy Ahmed I.,Gad Amany M.^ORCID,Elshazly Mohamed M.

Publisher

Elsevier BV

Reference34 articles.

1. ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-b-test-procedures-acceptance-criteria-biotechnological/biological-products-step-5_en.pdf.

2. Biosimilar medicines regulation https://www.tga.gov.au/resources/resource/guidance/biosimilar-medicines-regulation, (2018).

3. Progress made so far in implementing the partnerships for african vaccine manufacturing (PAVM) – framework for actionKigali, Rwanda;CDC,2021

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