Results 121 to 130 of about 158,299 (299)
British Journal of Clinical Pharmacology, EarlyView.Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink +9 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu +7 more
wiley +1 more source
Разработка и регистрация лекарственных средств, 2019 The matter presents a statistical evaluation of results obtained from GMP inspections of foreign pharmaceutical manufacturers held by Russian GMP-inspectorate in the year 2016.
V. A. Orlov
doaj
British Journal of Clinical Pharmacology, EarlyView.Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus +4 more
wiley +1 more source
ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS
Разработка и регистрация лекарственных средств, 2019 During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ...
O. S. Kobyakova +6 more
doaj
British Journal of Clinical Pharmacology, EarlyView.Chronic pain represents a complex debilitating condition that extends beyond the protective function of physiological pain, often persisting as an independent disease entity. Chronic primary and secondary pain syndromes reflect a multifaceted continuum involving nociceptive, neuropathic and nociplastic mechanisms.
Stefania Nobili +6 more
wiley +1 more source
, 2018 From om first meeting, we all agreed to use EMA Corporation as om company name and Groceries Truck as om service name. We all agreed to use EMA Corporation because it represents om partnership in offering the services. Groceries Truck name is taken as it
Masrin, Ramizah +2 more
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