The unprecedented challenges posed by the coronavirus disease 2019 (COVID-19) pandemic highlight the urgency for applying clinical pharmacology and model-informed drug development in (i) dosage optimization for COVID-19 therapies, (ii) approaching therapeutic dilemmas in clinical trial settings, and (iii) maximizing value of information from impacted non-COVID-19 trials. More than ever, we have a responsibility for adaptive evidence synthesis with a Totality of Evidence mindset in this race against time across biomedical research, clinical practice, drug development, and regulation.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267567 | PMC |
| http://dx.doi.org/10.1002/cpt.1879 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFThe Impact of Selenium on the Physiological Activity of Yeast Cells ATCC 7090 and CCY 20-2-26.
Front Biosci (Landmark Ed)
January 2025
Department of Food Biotechnology and Microbiology, Institute of Food Sciences, Warsaw University of Life Sciences - SGGW, 02-776 Warsaw, Poland.
Background: This study investigated the selenium-binding capacity of the biomass of two yeast strains, American Type Culture Collection (ATCC) 7090 and CCY 20-2-26.
Methods: The studies carried out methods of bioaccumulation by yeast biomass. Inorganic selenium was added to the culture media as an aqueous solution of NaSeO at concentrations ranging from 0 to 40 mg Se/L.
A Primer on the Role of TP53 Mutation and Targeted Therapy in Endometrial Cancer.
Front Biosci (Landmark Ed)
January 2025
Department of Oncology, The First Affiliated Hospital of Zhengzhou Hospital of Zhengzhou University, 450000 Zhengzhou, Henan, China.
Endometrial Cancer (EC) is one of the most common gynecological malignancies, ranking first in developed countries and regions. The occurrence and development of EC is closely associated with genetic mutations. mutation, in particular, can lead to the dysfunction of numerous regulatory factors and alteration of the tumor microenvironment (TME).
View Article and Find Full Text PDFVitamin Bs as Potent Anticancer Agents through MMP-2/9 Regulation.
Front Biosci (Landmark Ed)
January 2025
Department of Chemistry Education, Kongju National University, 32588 Gongju, Chungcheongnam-do, Republic of Korea.
In recent years, the role of coenzymes, particularly those from the vitamin B group in modulating the activity of metalloenzymes has garnered significant attention in cancer treatment strategies. Metalloenzymes play pivotal roles in various cellular processes, including DNA repair, cell signaling, and metabolism, making them promising targets for cancer therapy. This review explores the complex interplay between coenzymes, specifically vitamin Bs, and metalloenzymes in cancer pathogenesis and treatment.
View Article and Find Full Text PDFUpdate on the Progress of Musashi-2 in Malignant Tumors.
Front Biosci (Landmark Ed)
January 2025
Department of Hepatobiliary and Pancreatic Surgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, 030032 Taiyuan, Shanxi, China.
Since the discovery of the Musashi (MSI) protein, its ability to affect the mitosis of Drosophila progenitor cells has garnered significant interest among scientists. In the following 20 years, it has lived up to expectations. A substantial body of evidence has demonstrated that it is closely related to the development, metastasis, migration, and drug resistance of malignant tumors.
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!