Results 151 to 160 of about 4,078 (311)

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

Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process.
Allan Cramer   +4 more
wiley   +1 more source

Advantages and Disadvantages of Reluctance Step Motors in Comparison with Other Design Versions

open access: yes
Optional designs of step motors are compared in the paper. The authors show, that the reluctance step motors essentially outperform other type of step motors. They have a large torque, high accuracy of functioning, reliability, etc.
Pugačevs, Vladislavs   +3 more
core  

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

open access: yesBritish 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   +9 more
wiley   +1 more source

Comparative analysis of brushless DC and switched reluctance motors for optimizing off-grid water pumping. [PDF]

open access: yesSci Rep
Kumar A   +7 more
europepmc   +1 more source

Pharmacokinetic profiling of imatinib in relation to CYP3A4 activity in leukaemia patients

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Imatinib pharmacokinetics exhibit large interindividual variability because of differences in CYP3A4 activity—the main imatinib‐metabolizing enzyme. While therapeutic drug monitoring is effective, it requires steady‐state conditions and frequent sampling.
Anna Sofie Buhl Rasmussen   +14 more
wiley   +1 more source

Design and performance of switched reluctance motors

open access: yes, 2004
This paper deals with the design of switched reluctance motors (SRM). The effects of different parameters on the design are investigated. Finite element method is used to predict design and performance parameters.
Nagrial, Mahmood H.   +3 more
core  

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