Results 191 to 200 of about 266,111 (303)

Effectiveness of exercise prehabilitation before anterior cruciate ligament reconstruction on functional outcomes - a single-blinded randomized controlled trial. [PDF]

Sci Rep
Abel R, Niederer D, Glowa A, Hansen N, Wilke C, Offerhaus C.   +5 more
europepmc   +1 more source

Main factors associated with variability in the assessment of the objective response rate. A re‐analysis of the PHEREXA phase 3 clinical trial

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Local investigators (LIs) overestimate the objective response rate (ORR) in comparison to Blinded Independent Central Reviewers (BICR) in oncology. In this study, we re‐analysed data obtained in the PHEREXA trial (NCT01026142) with the following aims: i) to confirm at the single‐patient level the discrepancy observed by analysing ...
Gennaro Daniele, Tommaso Giovagnoli, Pierluigi Navarra, Cinzia Dello Russo   +3 more
wiley   +1 more source

Brand Manufacturer Coupons and Pharmaceutical Product Hopping.

JAMA Netw Open
Gibbons JB, DiStefano M, Anderson GF, Kesselheim AS, Socal M.   +4 more
europepmc   +1 more source

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

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Performance of Elecsys Anti-HEV IgG and IgM Assays for the Detection of Acute, Recent or Past Hepatitis E Virus Infection. [PDF]

Liver Int
Schemmerer M, Pflüger LS, Schneider T, Lu J, Kienle K, Meyer-Schlinkmann KM, Mühlbacher A, Polz J, Schennach H, Xie Q, Voitenleitner C, Wenzel J, Lütgehetmann M.   +12 more
europepmc   +1 more source

The impact of federations on student outcomes [PDF]

, 2009
Armstrong, Paul, Chapman, Christopher, Collins, Alison, Muijs, Daniel, Sammons, Pam   +4 more
core  

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

British Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher, Amina Džidić‐Krivić, Emma Pinjic, Nejra Selak, Kanita Omerbasic, Alexandar Chupin, Andrej Belancic, Almir Fajkic   +7 more
wiley   +1 more source

Control of Dental Plaque and Gingival Inflammation by Natural Ingredients-Based Mouthwash. [PDF]

Dent J (Basel)
Dutot M, Le Besco M, Mathurin O, Fong SB, Meuric V, Tanter C.   +5 more
europepmc   +1 more source

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

British 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, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source