Results 121 to 130 of about 19,957 (260)

Analyzing environmental sustainability methods for use earlier in the product lifecycle. [PDF]

J Clean Prod, 2018
Brundage MP, Bernstein WZ, Hoffenson S, Chang Q, Nishi H, Kliks T, Morris KC.   +6 more
europepmc   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

Identified research directions for using manufacturing knowledge earlier in the product lifecycle. [PDF]

Int J Prod Res, 2017
Hedberg TD, Hartman NW, Rosche P, Fischer K.   +3 more
europepmc   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

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

Total product lifecycle regulatory considerations and recommendations for generative AI-enabled medical devices. [PDF]

Eur Heart J Digit Health
Armoundas AA, Singh JP.
europepmc   +1 more source

Enabling Smart Manufacturing Research and Development using a Product Lifecycle Test Bed. [PDF]

Procedia Manuf, 2015
Helu M, Hedberg T.
europepmc   +1 more source

Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

British Journal of Clinical Pharmacology, EarlyView.
Abstract Introduction Active surveillance of adverse events using healthcare data is emerging as complementary to the monitoring of spontaneous reports and stand‐alone pharmacoepidemiologic studies. The risk of urinary tract infections (UTIs) was listed as a special warning for sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) when marketed in Europe
Haoxin Le, Dilsad Simay Peker, Lukas Frederic Westphal, Nikolai Brun, Christine Erikstrup Hallgreen, Morten Andersen   +5 more
wiley   +1 more source

Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance. [PDF]

Ther Innov Regul Sci
Alexe A, Wurst K, Balramsingh-Harry L, Apara O, Abramova N, Eisele O, Fernandes MFS, Garg A, Kovacs B, Lewis D.   +9 more
europepmc   +1 more source

Academic misconduct appeal services in China: Platform logics, self‐platformization and implications for integrity education

British Educational Research Journal, EarlyView.
Abstract Academic misconduct appeal services have quietly emerged within China's education marketplace, with commercial agencies promoting themselves on social media to assist international students facing misconduct hearings. While existing research on academic integrity has emphasized prevention and detection, far less attention has been paid to what
Gengyan Tang, Sarah Elaine Eaton, Wei Cai   +2 more
wiley   +1 more source