A REVIEW ON CLINICAL TRIALS: WHY TO INTRODUCE ZERO PHASE
- Medicine, Biology
It is concluded that Phase “0” in clinical trials can work as a useful parameter to measure drug safety at subtherapeutic level and the fundamental requirements of clinical studies conducted under an exploratory IND are reviewed and some common misconceptions regarding phase 0 trials are addressed.
Approaches to Phase 1 Clinical Trial Design Focused on Safety, Efficiency, and Selected Patient Populations: A Report from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee
- MedicineClinical Cancer Research
The goals and objectives of phase 1 clinical trials are changing to include further evaluation of endpoints such as molecular targeted effects, in addition to dose-toxicity profile of the investigational agent, and the most efficient ways to design and implement early clinical trials with novel therapeutics were evaluated.
Dose-toxicity models in oncology
- MedicineExpert opinion on drug metabolism & toxicology
The objective of this study was to provide a non-mathematical, reader-friendly overview of current and innovative dose-toxicity models in oncology with an emphasis on recent clinical advances, including the benefits of a Bayesian framework.
PHASES OF CLINICAL TRIALS: A REVIEW
The present review aims to discuss about the various phases of clinical trials, the characterization of which has arisen from drug trials.
Drug design, discovery and development and their safety or efficacy on human body
- Biology, Chemistry
Drug Design, often mentioned as rational drug design or just rational design. It is defined as the study of the shape of molecules in order to determine how they will bind receptors on cells or…
India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review
Evaluated India's clinical trial regulatory changes based on the existing literature, Indian researcher’s knowledge of the recent changes, and assessment of the impact of the new 2019 regulations, elaborating upon clinical trials in both the global and the Indian context.
Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients
- MedicineFrontiers in Medicine
Monitoring of the relevant mineral and contaminants levels in human subjects supplemented with a certified clinoptilolite material within three clinical trials with different supplementation regimens found increased levels of lead (Pb) were observed in PMA-zeolite-supplemented subjects, which decreased in the continued long-term supplementation trial.
Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies.
- Biology, MedicineBritish medical bulletin
This review summarizes key clinical trial data, current and future perspectives on stem cell-based products undergoing clinical trials, based on literature search and author research.
Development of monoclonal antibodies for the identification of novel invasion associated targets in human cancer.
Awareness and Perception of Drug Trials among Patients with Mental Disorders
- Psychology, MedicineOpen Journal of Psychiatry
Drug trials among psychiatric patients require an approach that will create an initial drug trial disorder—sensitive awareness and a design that will ensure that the consent process will take into cognizance the vulnerability of these patients; especially among females.