Results 11 to 20 of about 62,886 (320)

Pharmacovigilance inspections [PDF]

Indian Journal of Pharmacology, 2008
Patricia Fitzgerald
openalex   +3 more sources

Which Pharmacovigilance for Vaccines? [PDF]

Therapies, 2007
Vaccines are not separate health products but anti-infectious medicines administered for the large part prophylactically and for which the effect is immunological and not pharmacological. They should be evaluated by the usual methods of clinical pharmacology and pharmacovigilance, taking into account certain specificities (mechanism of action ...
Hervé Le Louët, Elisabeth Loupi, Françoise Haramburu, Atika Abelin, Didier Guillemot, Françoise Haramburu, Alexis Jacquet, C. Kreft-Jaïs, Odile Launay, Hervé Le Louët, Elisabeth Loupi, Muriel Malbezin   +11 more
openalex   +5 more sources

Pharmacovigilance in oncology [PDF]

International Journal of Clinical Pharmacy, 2018
AbstractBackground Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow ...
Paolo Baldo, Giulia Fornasier, Laura Ciolfi, Ivana Sartor, Sara Francescon   +4 more
openaire   +3 more sources

Identification of International Society on Thrombosis and Haemostasis major and clinically relevant non-major bleed events from electronic health records: a novel algorithm to enhance data utilisation from real-world sources

International Journal of Population Data Science, 2023
Introduction In randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH).
Alexander Hartenstein, Khaled Abdelgawwad, Frank Kleinjung, Stephen Privitera, Thomas Viethen, Tatsiana Vaitsiakhovich   +5 more
doaj   +1 more source

Suvorexant (Belsomra® Tablets 10, 15, and 20 mg): Japanese Drug-Use Results Survey

Drugs in R&D, 2018
Background We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. Methods A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were ...
Yuko Asai, Hideki Sano, Makoto Miyazaki, Mika Iwakura, Yoshikazu Maeda, Mitsuyoshi Hara   +5 more
doaj   +1 more source

Pharmacists in Pharmacovigilance: Can Increased Diagnostic Opportunity in Community Settings Translate to Better Vigilance? [PDF]

, 2014
The pharmacy profession has undergone substantial change over the last two to three decades. Whilst medicine supply still remains a central function, pharmacist’s roles and responsibilities have become more clinic and patient focused.
AG Granas, AI Wertheimer, B Gray, C Gonzalez-Gonzalez, C Su, Christine Randall, Consumers’ Association, Consumers’ Association, Consumers’ Association, D Brown, D Stewart, David Brown, DM Ashcroft, E Horsley, E Kroger, E Richardson, G Marchildon, GD Lansam, JK Jesson, Justine Howard, K Grootheest van, KB Blake, L Emmerton, L Hanna, M Jadeja, M Rosenthal, M Tobaiqy, MA Hadi, MP Smith, N Black, N Iqbal, P Chan, P Gavaza, P Rutter, Paul Rutter, S Keyhani, SS Sardas, T Kimura, V Paudyal, Z Austin   +39 more
core   +1 more source

How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias [PDF]

, 2020
Several pharmacoepidemiology networks have been developed over the past decade that use a distributed approach, implementing the same analysis at multiple data sites, to preserve privacy and minimize data sharing.
Brown, Jeffrey S., Henry, David A., Klungel, Olaf H., Platt, Richard, Platt, Robert W., Suissa, Samy   +5 more
core   +2 more sources

Pharmacovigilance in radiopharmaceuticals

Indian Journal of Nuclear Medicine, 2016
Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some ...
Rakesh Kumar, R. K. Verma, Vivekanandan Kalaiselvan, Rishi Kumar, Gyanendra Singh   +4 more
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Pharmacovigilance of herbal medicine

Journal of Ethnopharmacology, 2012
Pharmacovigilance is essential for developing reliable information on the safety of herbal medicines as used in Europe and the US. The existing systems were developed for synthetic medicines and require some modification to address the specific differences of medicinal herbs.
Debbie Shaw, Graeme Ladds, Pierre Duez, Elizabeth M. Williamson, Chan Kelvin   +4 more
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Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File

Безопасность и риск фармакотерапии, 2020
The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF ...
N. G. Goloenko, R. I. Yagudina, A. Yu. Kulikov, V. G. Serpik, M. V. Protsenko, D. G. Karapetyan   +5 more
doaj   +1 more source