New clinical trial designs in the era of precision medicine
Sign Up to like & getrecommendations! Published in 2019 at "Molecular Oncology"
DOI: 10.1002/1878-0261.12465
Abstract: Cancer treatment has made significant strides towards the promise of personalized medicine. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing… read more here.
Keywords: medicine; drug development; trial designs; oncology ... See more keywords
Acute myeloid leukemia drug development in the post‐venetoclax era
Sign Up to like & getrecommendations! Published in 2019 at "American Journal of Hematology"
DOI: 10.1002/ajh.25556
Abstract: Much has been written and discussed related to the recent plethora of drug approvals by the United States Food and Drug Administration (FDA) for acute myeloid leukemia (AML). This topic has been met with appropriate… read more here.
Keywords: drug development; venetoclax; myeloid leukemia; drug ... See more keywords
Drug re‐engineering and repurposing: A significant and rapid approach to tuberculosis drug discovery
Sign Up to like & getrecommendations! Published in 2022 at "Archiv der Pharmazie"
DOI: 10.1002/ardp.202200214
Abstract: The prevalence of tuberculosis (TB) remains the leading cause of death from a single infectious agent, ranking it above all other contagious diseases. The problem to tackle this disease seems to become even worse due… read more here.
Keywords: drug discovery; tuberculosis; classes compounds; drug development ... See more keywords
Changing incentives to ACCELERATE drug development for paediatric cancer
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DOI: 10.1002/cam4.5627
Abstract: More effective incentives are needed to motivate paediatric oncology drug development, uncoupling it from dependency on adult drug development. Although the current European and North‐American legislations aim to promote drug development for paediatrics and rare… read more here.
Keywords: changing incentives; drug development; cancer; incentives accelerate ... See more keywords
Recent Drug Development and Medicinal Chemistry Approaches for the Treatment of SARS‐CoV‐2 and Covid‐19
Sign Up to like & getrecommendations! Published in 2022 at "Chemmedchem"
DOI: 10.1002/cmdc.202200440
Abstract: COVID‐19, caused by SARS‐CoV‐2 infection, continues to be a major public health crisis around the globe. Development of vaccines and the first cluster of antiviral drugs has brought promise and hope for prevention and treatment… read more here.
Keywords: development; chemistry; treatment; drug development ... See more keywords
Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1106
Abstract: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report a model‐informed drug development approach for bridging efficacy from immediate‐release (IR) to extended‐release (XR) tofacitinib formulations in… read more here.
Keywords: tofacitinib; efficacy; release; drug development ... See more keywords
Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy
Sign Up to like & getrecommendations! Published in 2023 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1240
Abstract: Pexidartinib, an oral small molecule inhibitor of the colony‐stimulating factor 1 receptor, is approved for treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to… read more here.
Keywords: meal; low fat; dosing regimen; fat meal ... See more keywords
Model‐Informed Drug Development for Long‐Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium
Sign Up to like & getrecommendations! Published in 2021 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.928
Abstract: Poor adherence to prescribed medications significantly impacts the U.S. health care system.1–4 Given the human and financial consequences, the development of strategies for improving adherence to prescribed medications is imperative. Long-acting injectable (LAI) drug products… read more here.
Keywords: drug development; long acting; drug; pharmacology ... See more keywords
Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2092
Abstract: Accelerated drug development for diseases with high unmet need demands patient focus without compromising scientific rigor. Precision dosing informed by physiologically-based pharmacokinetic (PBPK) models will enable inclusive clinical trials and narrow the gap between clinical… read more here.
Keywords: drug development; mass balance; based pharmacokinetic; precision dosing ... See more keywords
Model Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2491
Abstract: Leveraging limited clinical and non-clinical data through modeling approaches facilitates new drug development and regulatory decision making amid the Coronavirus Disease 2019 (COVID-19) pandemic. Model-informed drug development (MIDD) is an essential tool to integrate those… read more here.
Keywords: drug development; model informed; new drug; drug ... See more keywords
Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2528
Abstract: Global regulatory agencies have transformed their approach to approvals in their processes for formal review of the safety and efficacy of new drugs. Opportunities for innovation have expanded because of the coronavirus disease 2019 (COVID‐19)… read more here.
Keywords: innovative trial; designs orphan; trial designs; trial ... See more keywords