Results 151 to 160 of about 281,370 (287)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló   +5 more
wiley   +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

open access: yesBritish 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

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

open access: yesBritish 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

First‐Line Osimertinib in Patients with EGFR‐Mutant Advanced Non‐Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study

open access: yesThe Oncologist, EarlyView., 2021
Abstract Lessons Learned Osimertinib has confirmed effectiveness in this real‐world population of patients with EGFR‐mutant advanced non‐small cell lung cancer. Thromboembolic events occur more frequently than previously reported, suggesting a thrombotic diathesis that requires further investigation. Patients with at least three metastatic sites, brain
Martina Lorenzi   +21 more
wiley   +1 more source

Effect of carbamazepine on the pharmacokinetics of vepdegestrant, a PROteolysis TArgeting Chimera estrogen receptor degrader, in healthy adults

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To evaluate the effects of carbamazepine, a strong cytochrome P450 (CYP)3A4 inducer, on the pharmacokinetics and safety of vepdegestrant, a PROteolysis TArgeting Chimera estrogen receptor degrader. Methods This was a phase 1, open‐label, fixed‐sequence, two‐period study in healthy adult participants.
Hechuan Wang   +7 more
wiley   +1 more source

Analysis of interstitial lung disease in pharmacovigilance databases: Coding challenges and interpretation biases—An update

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Clinically, interstitial lung disease (ILD) is a heterogeneous group of respiratory disorders. Due to their low incidence, pharmacovigilance database analysis is useful to detect them. Precise diagnosis is challenging as well as coding in these databases. Query criteria are among the key elements for a good signal detection.
Romane Freppel   +4 more
wiley   +1 more source

Molecular imaging of tucatinib-induced cellular and TME changes in preclinical models of HER2 + breast cancer. [PDF]

open access: yesBreast Cancer Res Treat
Song PN   +5 more
europepmc   +1 more source

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