Phase 0 Radiopharmaceutical–Agent Clinical Development
نویسندگان
چکیده
منابع مشابه
Designing phase 0 cancer clinical trials.
Phase 0 trials are designed primarily to evaluate the pharmacodynamic and/or pharmacokinetic properties of selected investigational agents before initiating more traditional phase I testing. One of the major objectives of phase 0 trials is to interrogate and refine a target or biomarker assay for drug effect in human samples implementing procedures developed and validated in preclinical models....
متن کاملPatient perspectives on phase 0 clinical trials.
Phase 0 clinical trials are considered first-in-human studies that require extensive agent characterization and target assay development before administration. Phase 0 clinical trial goals can include assessing the pharmacokinetic-pharmacodynamic relationships of an investigational drug. They cover the rational transition from preclinical to clinical drug development, which includes an assessme...
متن کاملPhase 0 - Microdosing strategy in clinical trials
Drug development is an activity that is long, complex and expensive. In 2004, attrition in the drug development paradigm prompted the US Food and Drug Administration (FDA) to introduce its 'Critical Path' document, which highlighted the serious discordance between major scientific advances and limited drug development process. One issue addressed was that of microdosing. The concept of microdos...
متن کاملPhase 0 clinical trials will overcome stagnation of anticancer drug development?
Recent guidance from the US Food and Drug Administration supports the conduct of a new type of exploratory clinical trials, commonly called phase 0 clinical trials, on the development of innovative anticancer agents, particularly targeted agents. Phase 0 clinical trials are controversial mainly because of the lack of clinical benefit to the participant patients. However, it was recognized that ...
متن کاملMicrodosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development
A number of drivers and developments suggest that microdosing and other phase 0 applications will experience increased utilization in the near-to-medium future. Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities are important drivers in favor of these approaches, and can be expected only to increase in their releva...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Frontiers in Oncology
سال: 2020
ISSN: 2234-943X
DOI: 10.3389/fonc.2020.01310