Results 151 to 160 of about 44,266 (294)

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

open access: yesBritish 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   +5 more
wiley   +1 more source

Precision medicine in paediatrics: Progress and priorities

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain   +3 more
wiley   +1 more source

UGT1A1 genotype testing for irinotecan: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Irinotecan, a topoisomerase I inhibitor, is available as both non‐pegylated and pegylated formulations. The non‐pegylated formulation is licensed for use in advanced colorectal cancer either in combination with other agents or as monotherapy.
Dharmisha Chauhan   +24 more
wiley   +1 more source

Safety and pharmacokinetics of mosliciguat, a new, inhaled soluble guanylate cyclase activator, in healthy adult subjects

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Mosliciguat (BAY 1237592), the first soluble guanylate cyclase (sGC) activator in a dry powder inhaler (DPI), could potentially treat pulmonary hypertension with a more targeted delivery than systemic sGC stimulators. We report safety and tolerability of mosliciguat in healthy men.
Johannes Nagelschmitz   +7 more
wiley   +1 more source

Physical Activity Prescription in Primary Health Care: An Ethical Analysis. [PDF]

open access: yesHealthcare (Basel)
Batuecas-Caletrio J   +5 more
europepmc   +1 more source

Factors associated with prevalence and types of 'may be fit' advice on fit notes: a cross-sectional primary care analysis.

open access: yesThe British journal of general practice : the journal of the Royal College of General Practitioners, 2014
C. Shiels, M. Gabbay, J. Hillage
semanticscholar   +1 more source

Development of a population pharmacokinetic model using combined paediatric and adult data for four pulmonary arterial hypertension drugs

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Pulmonary arterial hypertension (PAH) is a syndrome characterized by elevated pulmonary artery pressure. We developed a population pharmacokinetic (PPK) model using combined plasma drug concentration data from Japanese paediatric (<15 years) and adult (≥15 years) patients with PAH to investigate the pharmacokinetic characteristics of PAH ...
Motoyasu Miura   +13 more
wiley   +1 more source

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