Authorisation and Withdrawal of Pharmaceutical Innovations in the European Union and in the United States (1995-2003) [PDF]
This is a comparative study of the average and median approval times for pharmaceutical innovations (new molecular entities -NMES- and new biologics), authorised in the United States (US) and in the European Union (EU) under the centralised procedure ...
Cabiedes Miragaya, Laura
core
Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety
Patient Preference and AdherenceCarlos De las Cuevas,1 Emilio J Sanz,2,3 Jose de Leon4,5 1Department of Internal Medicine, Dermatology, and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain; 2Department of Physical
De las Cuevas C, Sanz EJ, de Leon J
doaj
Revista de Saúde Pública, 2012 OBJETIVO: Identificar os principais medicamentos falsificados apreendidos pela Polícia Federal brasileira e os estados em que houve a apreensão. MÉTODOS: Estudo retrospectivo descritivo dos laudos periciais elaborados por Peritos Criminais da Polícia ...
Joseane Ames, Daniele Zago Souza
doaj
Introducing auto-disable syringes to the national immunization programme in Madagascar
Bulletin of the World Health Organization, 2003 OBJECTIVE: To evaluate the safety and coverage benefits of auto-disable (AD) syringes, weighed against the financial and logis- tical costs, and to create appropriate health policies in Madagascar.
Drain Paul K. +3 more
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Manufacturing Barriers to Biologics Competition and Innovation [PDF]
, 2016 As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
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Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON [PDF]
, 2016 core +1 more source
Incentivizing Postmarketing Pharmaceutical Product Safety Testing with Extension of Exclusivity Periods [PDF]
, 2008 Kushner, Leslie
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Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024. [PDF]
Clin TrialsLi LY +3 more
europepmc +1 more source
Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend. [PDF]
Clin Pharmacol TherOkami S, Shimotsumagari K, Sadatsuki Y.
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Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care. [PDF]
Ital J PediatrColombo M, Plebani A, Agosti M.
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