Results 231 to 240 of about 140,577 (292)

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

An integrated assessment of water-energy-food benefits from small hydropower refurbishment in rural China. [PDF]

iScience
Li J, Tian G, Wu Z, Liu X, Xia Q, Lu C.
europepmc   +1 more source

Digital diagnostics, biomarkers and therapeutics in an evolving healthcare system: From promise to practice

British Journal of Clinical Pharmacology, EarlyView.
Abstract Health care is shifting towards a digital‐guided system, integrating digital diagnostics, biomarkers and therapeutics in many care pathways. However, despite rapid technological advancement and preliminary adoption accelerated by the COVID‐19 pandemic, a significant implementation gap persists. This narrative review explores the causes of this
Mees H. P. Stoop, Gertjan J. A. Driessen, Adam F. Cohen, Matthijs D. Kruizinga   +3 more
wiley   +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

Construction of a balanced scorecard-based performance evaluation indicator system for research management in key biomedical research laboratories: An observational study. [PDF]

Medicine (Baltimore)
Zhou B, Niu J, Wang Q.
europepmc   +1 more source

HLA genotype testing for carbamazepine, oxcarbazepine and eslicarbazepine: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

British Journal of Clinical Pharmacology, EarlyView.
Carbamazepine is licensed in the United Kingdom for the treatment of epilepsy, bipolar disorder and trigeminal neuralgia. The related compounds oxcarbazepine and eslicarbazepine are licensed for the treatment of epilepsy. These drugs can cause immune‐mediated hypersensitivity reactions, which typically affect the skin, and can be of variable severity ...
Lucy Galloway, Cinzia Dello Russo, Nicholas Bass, Elvira Bramon, Helen Cross, Natalie Curley, Sarah Curran, Helen Davies, Jana De Villiers, William Evans, Bernhard Frank, Alice Groves, Judith Hayward, Jon Higham, Dyfrig A. Hughes, Shwe Sin Kyaw, Anthony G. Marson, Ailsa McLellan, Seth Mensah, Francis O'Neill, Jane Sargison, Sanjay M. Sisodiya, Jill Swan, Joanna M. Zakrewska, Munir Pirmohamed   +24 more
wiley   +1 more source

Co-Design of an Electronic Patient Record-Integrated COPD Self-Management App: The My Lung Health Coach Companion. [PDF]

Int J Chron Obstruct Pulmon Dis
Farrer C, Manankil D, Thuringer K, Ahmed K, Man K, Tohob SA, Kouri A.   +6 more
europepmc   +1 more source

Method for and potential value of reflexive stakeholder mapping of a policy evaluation team: the example of the national evaluation of the NHS Pharmacy First scheme. [PDF]

Health Res Policy Syst
Matuluko A, Lalani M, Chu IY, Pacho A, Mays N, Glover RE.   +5 more
europepmc   +1 more source

Views, Barriers and Facilitators  of Policymakers, Pharmacists and Community Health Representative in Managing Unused Medicine in a Socioeconomically Diverse District in Indonesia. [PDF]

F1000Res
Syamsudin RAMR, Kristina SA, Wiedyaningsih C, Lai PSM.   +3 more
europepmc   +1 more source

Stakeholder engagement as a valuable tool to improve the relevance of research regarding framework development. [PDF]

npj Vet Sci
Reyneke RA, Richens IF, Buchanan H, Davies EB, Brennan ML.   +4 more
europepmc   +1 more source