Results 201 to 210 of about 17,439 (263)

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

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer   +4 more
wiley   +1 more source

Uncovering the Impact of Center of Rotation of Angulation Location on High Tibial Osteotomy in Knee Osteoarthritis: A Potential Pathway for Improved Outcomes. [PDF]

open access: yesCartilage
Janssen Y   +13 more
europepmc   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

open access: yes
British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera   +7 more
wiley   +1 more source

Legal remedies for employees if they are injured in the workplace

British Journal of Nursing, 2003
Case Scenario Angela, a healthcare assistant who worked In the operating theatre, was severely Injured by a scalpel thrown Into the bin that was meant for operating theatre linen. This Is a common problem faced by the theatre employees who have made frequent complaints about the dangers. What Is the law?
openaire   +2 more sources

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