Results 181 to 190 of about 242,891 (382)
British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
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 +3 more
wiley +1 more source
PENGGUNAAN DIKSI INDRIA PADA NOVEL NGULANDARA DALAM BUKU EMAS SUMAWUR ING BALUARTI KARYA PARTINI B [PDF]
, 2012 Haryanti Haryanti
openalex
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 +5 more
wiley +1 more source
Explaining differences in environmental policy across Europe: the importance of informal institutions, incomplete information and path dependence [PDF]
What factors shape environmental policies across Europe? In order to answer this question most economists would probably adopt a Public Choice approach.
Wätzold, Frank
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 +7 more
wiley +1 more source
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 +4 more
wiley +1 more source