Results 11 to 20 of about 4,926,176 (337)

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.

JAMA Intern Med, 2020
This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.
Chen EY, Haslam A, Prasad V.
europepmc   +2 more sources

From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt [PDF]

Pharmaceuticals
Pharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually.
Fadya M. Elgarhy, Abdallah Borham, Noha Alziny, Khlood R. AbdElaal, Mahmoud Shuaib, Abobaker Salem Musaibah, Mohamed Ali Hussein, Anwar Abdelnaser   +7 more
doaj   +2 more sources

The use of mechanistic evidence in drug approval. [PDF]

J Eval Clin Pract, 2018
The role of mechanistic evidence tends to be under‐appreciated in current evidence‐based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme
Aronson JK, La Caze A, Kelly MP, Parkkinen VP, Williamson J.   +4 more
europepmc   +2 more sources

Approval success rates of drug candidates based on target, action, modality, application, and their combinations

Clinical and Translational Science, 2021
The current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%–20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select
Shingo Yamaguchi, Masayuki Kaneko, Mamoru Narukawa   +2 more
doaj   +2 more sources

Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan [PDF]

Pharmacology Research & Perspectives, 2023
Recently, post‐marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems.
Rieko Saito, Seiko Miyazaki
doaj   +2 more sources

ChemAP: predicting drug approval with chemical structures before clinical trial phase by leveraging multi-modal embedding space and knowledge distillation [PDF]

Scientific Reports
Recent studies showed that the likelihood of drug approval can be predicted with clinical data and structure information of drug using computational approaches. Predicting the likelihood of drug approval can be innovative and of high impact.
Changyun Cho, Sangseon Lee, Dongmin Bang, Yinhua Piao, Sun Kim   +4 more
doaj   +2 more sources

Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022. [PDF]

Orphanet J Rare Dis
Wang S, Liu X, Zou Y, Tang Y, Zuo W, Jiang R, Shang J, Tian X, Liu Q, Xu T, Zhang B, Zhang S.   +11 more
europepmc   +2 more sources

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process. [PDF]

J Manag Care Spec Pharm, 2017
Mattingly TJ, Simoni-Wastila L.
europepmc   +2 more sources

The Impact of Label Changes (Boxed Warning) on Real-World Febuxostat Utilization in Patients with Gout: A Cross-Sectional Drug Utilization Study

Rheumatology and Therapy, 2023
Introduction This drug utilization study evaluated the impact of 2019 label changes on real-world febuxostat utilization among patients with gout. We describe the numbers and proportions of patients initiating febuxostat as new users (allopurinol-naïve ...
Alexandra Z. Sosinsky, Yufei Song, Lhanoo Gunawardhana, Syd Phillips, Matt Page   +4 more
doaj   +1 more source

Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change. [PDF]

Crohns Colitis 360
Sahn B, Maltz RM, Rosh JR.
europepmc   +3 more sources