Example: air traffic controller
Guidelines on similar biologics
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GUIDELINES ON SIMILAR BIOLOGICS
cdsco.nic.inGuidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India 7 2. Background & Objectives CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality
REPORT - Biotechnology by Amgen
www.amgenbiotech.com3. WHAT ARE BIOLOGICS AND BIOSIMILARS? A biologic medicine is a large molecule derived from living cells that is used to treat or prevent disease, such as a therapeutic protein, DNA vaccine, monoclonal antibody (i.e., MAB) or fusion
Guidelines on Similar Biologic: Regulatory …
www.cdsco.nic.inGuidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India _____ 11.
GUIDELINES ON EVALUATION OF SIMILAR ... - …
www.who.intenglish only final expert committee on biological standardization geneva, 19 to 23 october 2009 guidelines on evaluation of similar biotherapeutic products (sbps)