Results 251 to 260 of about 995,533 (306)

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

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

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm   +2 more
wiley   +1 more source

New therapeutic options for metabolic‐associated steatotic liver disease

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
An increasing number of patients are being diagnosed with metabolic dysfunction‐associated steatotic liver disease (MASLD). MASLD results from disturbances in hepatic lipid metabolism and is associated with an increased risk of cirrhosis and hepatocellular carcinoma and significant extrahepatic morbidity, including cardiovascular disease and ...
Tessa Straatmijer, Midas Mulder
wiley   +1 more source

Home - About - Disclaimer - Privacy