Results 61 to 70 of about 22,949 (256)

Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products

Journal of Pharmaceutical Policy and Practice
Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products.
Chieko Ishiguro, Yasutomo Teshima, Harumasa Nakamura   +2 more
doaj   +1 more source

Preferential prescribing of linagliptin in type 2 diabetes patients in an expanded post‐marketing surveillance study in Japan

Journal of Diabetes Investigation, 2019
Aims/Introduction To evaluate linagliptin prescribing in type 2 diabetes mellitus patients with different comorbidities, an expanded Japanese post‐marketing surveillance also collected baseline data for patients initiating other glucose‐lowering drugs ...
Soulmaz Fazeli Farsani, Atsushi Taniguchi, Rie Ikeda, Kimberly G Brodovicz, Dorothee B Bartels   +4 more
doaj   +1 more source

Post-Marketing Surveillance: Drug Epidemiology

Journal of International Medical Research, 1981
A description of the need for and appropriateness of a multi-component application of epidemiological methods to the post-marketing evaluation of drugs is presented. There is a need for the development of the art and science of Drug Epidemiology. The large number of drugs introduced over the last 40 years and the number of interventions constitute an ...
openaire   +2 more sources

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari, Caroline S. Copeland, Georgia C. Richards   +2 more
wiley   +1 more source

British National Formulary Guidance on prescribing in pregnancy: A descriptive cross‐sectional study

British Journal of Clinical Pharmacology, EarlyView.
Aim To assess how well pregnancy‐specific guidance within the British National Formulary supports healthcare professionals to facilitate safe and effective medication use. Methods We performed a manifest content analysis of the text of all pregnancy sections within British National Formulary drug monographs, with inductive and iterative coding.
Hannah Johnson, Cleodie Swire, Lakshiv Dhingra, Toqa El‐Nahhas, Michelle Essiam, Salma Muse, Maria Tonkova, Nazmin Begum, Joan Morris, Emma Baker   +9 more
wiley   +1 more source

Problems of post‐marketing surveillance. [PDF]

British Journal of Clinical Pharmacology, 1983
W M, Castle, J T, Nicholls, C C, Downie
openaire   +2 more sources

Pregnancy‐related effect on elexacaftor, tezacaftor and ivacaftor pharmacokinetics in women with cystic fibrosis

British Journal of Clinical Pharmacology, EarlyView.
Aim The number of pregnancies among women with cystic fibrosis (wwCF) has steadily increased over the past decade. However, the pharmacokinetics (PK) of elexacaftor–tezacaftor–ivacaftor (ETI) during gestation remains uncharacterized, despite its widespread use in this population.
Paulette Magnas, Naim Bouazza, Frantz Foissac, Saïk Urien, Léo Froelicher‐Bournaud, Gabrielle Lui, Victoria Guillemart, Nicolas Carlier, Jennifer Da Silva, Johanna Fesenbeckh, Reem Kanaan, Isabelle Honoré, Clémence Martin, Jean‐Marc Treluyer, Vassilis Tsatsaris, Pierre‐Régis Burgel, Sihem Benaboud   +16 more
wiley   +1 more source

Cardiovascular and neuropsychiatric outcomes with PCSK9 inhibitors in atherosclerotic cardiovascular disease: A retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Study design and main findings. After 1:1 propensity score matching, 60 885 PCSK9 inhibitor users and 60 885 statin‐only users with ASCVD were compared. Kaplan–Meier curves show 12‐month cumulative event‐free survival for MACE, psychiatric disease, and neurodegenerative disease.
Tianshu Gu, Yang Chen, Nan Zhang, Uazman Alam, Riccardo Proietti, Tong Liu, Kang‐Yin Chen, Gregory Y. H. Lip   +7 more
wiley   +1 more source

Phase IV of Drug Development

Perspectives in Clinical Research, 2010
Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development.
Viraj Suvarna
doaj