Drug SafetyRegev A, Seeff LB, Merz M, Ormarsdottir S, Aithal GP, Gallivan J, Watkins PB. Causality assessment for suspected DILI during clinical phases of drug development. Drug Saf 2014; 37 Suppl 1: S47-S56 [PMID: 25352327 DOI: 10.1007/s40264-014-0185-4]...
only a single antifungal drug has been approved during the last decade. Resistance, toxicity, drug interactions and restricted routes of administration remain unresolved issues. This review focuses on new antifungal compounds which are currently in various clinical phases of development. We discuss two ...
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Smooth Drug Development en info@smoothdd.com Hide ← Clinical trials in Europe and Asia < 123456 > International full-service Contract Research Organization. Effective teamworkand reliable accuracy in clinical trials.Learn more ? services Phases of clinical trials...
A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting Phase II and III trials. It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates ...
It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates are reduced. In this article, we argue that moving from the traditional clinical development approach based on sequential, distinct phases towards a ...
Lastly, this model may then assist with optimizing dosing regimens and efficacious dose selection, which would make it translationally applicable from the preclinical through the clinical phases of drug development. Methods Model structure and dynamics We have developed a multiscale PB-QSP model for ...
In drug development, clinical trials consist of four phases, with each phase having a different purpose to aid in providing scientists answers to proposed scientific questions. Researchers start with smaller groups of people and more focused objectives, gradually working up to larger trials aimed at ...
High orphan drug prices have gained the attention of payers and policy makers. These prices may reflect the need to recoup the cost of drug development from a small patient pool. However, estimates of the cost of orphan drug development are sparse. Using
Summary This chapter contains sections titled: The phases of drug development: an obsolete model Concepts of bias and statistical necessities Prospective definitions: the only way to interpret what you measure Historical clinical trials Limitations of controlled clinical trials The clinical development plan...