Database studies in post-marketing surveillance in Japan: Perspective from the industry
نویسندگان
چکیده
منابع مشابه
Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan†
PURPOSE To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. METHODS A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of...
متن کاملWhich post-marketing database and studies does EMEA require.
The European process for assessment of pharmaceutical products is complex and presents with diVerent levels. There is the European level with two major procedures resulting in decisions on approval after applications to market a pharmaceutical product in European countries. One is the centralised procedure organised by the European Medicines Evaluation Agency (EMEA). The other one is the mutual...
متن کاملPost-marketing surveillance of buprenorphine.
PURPOSE This study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long-term treatment of opiate dependence. METHODS The current investigation was conducted through a multi-centric...
متن کاملPost Marketing Surveillance on Propranolol and Atenolol Tablets Manufactured in Iran
Propranolol, a prototypical b-adrenergic receptor antagonist and atenolol, a cardio-selective b-antagonist are widely used in therapeutic regimens for treatment of hypertensive patients. In Iran, several pharmaceutical manufacturers formulate these two b-blockers. As the formulation of a dosage form is essential for the patient's safety and drug efficacy, in this study we aimed to evalu...
متن کاملSafety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan
INTRODUCTION Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillan...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Proceedings for Annual Meeting of The Japanese Pharmacological Society
سال: 2018
ISSN: 2435-4953
DOI: 10.1254/jpssuppl.wcp2018.0_sy38-4