Search Results for: PHARMACOLOGY MODELS Early Phase Pharmacodynamic
Articles
PHARMACOLOGY MODELS - Early Phase Pharmacodynamic Models for Respiratory Drug Candidates June 30, 2016
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
CicloMed Expands Fosciclopirox Phase 1 Trial December 4, 2019
CicloMed LLC recently announced the expansion of its fosciclopirox clinical development program. The fosciclopirox first-in-human Phase 1 trial has been...CLINICAL TRIALS - Outsourcing Early-Stage Clinical Trials: How to Mitigate Costs & Risk June 3, 2014
Roundtable Discussion: Contributor Cindy H. Dubin gathered leading CROs together to discuss the benefits of outsourcing early-stage clinical trials, how to mitigate the risks, and lower costs in the process.
ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change? May 1, 2017
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
