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Web Resource
Web Resource
Web Resource
BIOFUTUR, ISSN 0294-3506, 01/1997, Issue 163, pp. 24 - 26
Journal Article
Journal Article
Journal of the American College of Cardiology, ISSN 0735-1097, 01/2018, Volume 71, Issue 4, pp. 429 - 438
Journal Article
Nature Biotechnology, ISSN 1087-0156, 12/2012, Volume 30, Issue 12, pp. 1179 - 1185
  With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are... 
PRODUCTS | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | Biotechnology | Drug Labeling | Guidelines as Topic | European Union | Humans | Antibodies, Monoclonal | Biosimilar Pharmaceuticals | Drug Approval - legislation & jurisprudence | Monoclonal antibodies | Laws, regulations and rules | Forecasts and trends | Biomimetics | Regulatory approval | Index Medicus
Journal Article
Health Affairs, ISSN 0278-2715, 2013, Volume 32, Issue 10, pp. 1803 - 1810
Biologics are medicines derived from a biological source. Their high prices and rapid uptake have raised hopes that with the gradual expiration of patents on... 
DRUG | HEALTH POLICY & SERVICES | MARKET | BIOLOGICS | CARE | HEALTH CARE SCIENCES & SERVICES | Biosimilar Pharmaceuticals - economics | Pharmacovigilance | Legislation, Drug | United States | Europe | United States Food and Drug Administration | Studies | Biological products | Health care expenditures | FDA approval | Impact analysis | Index Medicus
Journal Article
Santé Publique, ISSN 0995-3914, 2018, Volume 30, Issue 2, pp. 187 - 196
Cet article porte un éclairage sur un concept peu connu des acteurs de la santé publique en France : la science réglementaire ou regulatory science , utilisé... 
Journal Article
Journal Article
Les Tribunes de la santé, ISSN 1765-8888, 2010, Volume 27, Issue 2, pp. 61 - 78
RésuméL'expertise sur le médicament, à des fins d'autorisation de mise sur le marché (l'octroi d'une AMM est obligatoire avant toute commercialisation d'un... 
Journal Article
Pharmaceutical Research, ISSN 0724-8741, 7/2018, Volume 35, Issue 7, pp. 1 - 12
Journal Article
SANTE PUBLIQUE, ISSN 0995-3914, 03/2018, Volume 30, Issue 2, pp. 187 - 196
This article sheds light on a concept little known to public health actors in France: regulatory science, used to describe the range of scientific activities... 
PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH | Health policy | Risk assessment | Regulatory science | CAUSALITY | Legislation & jurisprudence | Regulation | MODEL | PHARMACOVIGILANCE | Standards | Index Medicus
Journal Article
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