The utilization of pharmacogenomics (PGx) in drug development is increasing as pharmaceutical companies and regulatory agencies work to understand variation in response to medications. The implementation of PGx in clinical trials requires a number of considerations that begin early at the point of program development for a compound. This article will discuss the issues involved in mobilizing a PGx study during the conduct of a clinical trial, including the development of a PGx hypothesis, the identification of genetic markers for analysis, PGx platform selection and assay development, as well as challenges that arise in relation to global laws and regulations related to genetic research and logistical/timeline concerns in the execution of a PGx analysis.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.2217/pgs.13.109 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors.
AAPS J
January 2025
Department of BioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA.
Protein-based therapeutics may elicit undesired immune responses in a subset of patients, leading to the production of anti-drug antibodies (ADA). In some cases, ADAs have been reported to affect the pharmacokinetics, efficacy and/or safety of the drug. Accurate prediction of the ADA response can help drug developers identify the immunogenicity risk of the drug candidates, thereby allowing them to make the necessary modifications to mitigate the immunogenicity.
View Article and Find Full Text PDFPostoperative pain in primary root canal treatments after Er: YAG laser-activated irrigation: a systematic review and meta-analysis.
Lasers Med Sci
January 2025
Universidade Federal de Pelotas, Pelotas, Brazil.
This systematic review aimed to compare postoperative pain in endodontic treatments using PIPS Er: YAG laser-activated irrigation (LAI) versus conventional needle irrigation. An electronic search was conducted to identify randomized clinical trials (RCT) investigating postoperative pain in patients who underwent root canal treatments in permanent teeth using PIPS Er: YAG laser-activated irrigation or conventional needle irrigation. Two reviewers performed study selection, data extraction, risk of bias assessment (RoB 2.
View Article and Find Full Text PDFAdjunctive therapea - a promising method in the treatment of periodontal disease.
Clin Oral Investig
January 2025
Department of Oral and Maxillofacial Surgery, Yerevan State Medical University, Yerevan, Armenia.
Objectives: The aim of the study is to compare the clinical efficacy of the application of "Armenicum" paste as an adjunct to SRP for the non-surgical treatment of patients with periodontitis.
Methods: The current RCT prospective study was conducted on 157 patients with chronic periodontitis. The patients were blind randomly assigned into two groups: Group A (SRP + Armenicum" paste) 81 patients (42 males and 39 females, 37 to 68 years) and Group B (SRP) 76 patients (39 males and 37 females, 37 to 68 years).
PI3K/AKT/mTOR Targeting in Colorectal Cancer Radiotherapy: A Systematic Review.
J Gastrointest Cancer
January 2025
Medical Physics Research Center, Basic Sciences Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Background: Radioresistance is a major challenge in the treatment of patients with colorectal cancer (CRC) and impairs the efficacy of radiotherapy. The PI3K/AKT/mTOR signaling pathway plays a critical role in CRC and contributes to the development of radioresistance. Accordingly, targeting this signaling pathway may be a promising strategy to improve oncotherapy.
View Article and Find Full Text PDFEfficacy of repetitive transcranial magnetic stimulation for phantom limb pain- a meta analysis of randomized controlled trials.
Neurol Sci
January 2025
Mayo Clinic, Rochester, MN, USA.
Introduction: Phantom limb pain (PLP) is a neuropathic syndrome experienced by the majority of amputees. Various treatment options are available for amputees suffering from PLP including pharmacological, psychological and neuromodulation techniques. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has proven its efficacy in alleviating PLP.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!