Results for 'pharmacology'
Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities
quantitative clinical pharmacology, T-Cell, TDB, bispecificss
The pharmacological response of TDBs involves complex interactions between T-cells, tumor cells, and TDBs, posing challenges in understanding pharmacokinetics, tissue distribution, target engagement, and exposure-response relationships. Dosing strategy is crucial for determining the therapeu…
Nov 18th • 15 mins read
Alison Betts, Piet H. van der Graaf
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach
Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…
Jun 24th • 18 mins read
Kirill Peskov, Ivan Azarov, Lulu Chu, Veronika Voronova, Yuri Kosinsky, Gabriel Helmlinger
Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology
immuno-oncology, mechanistic models, tumor vs. immune system, systems pharmacology, pharmacokinetics, pharmacodynamics, molecular and cellular biomarkers
There has been significant growth in the development of immuno-modulating pharmacological treatments for various cancers following the approval of the first immune checkpoint inhibitor. Challenges in immuno-oncology (IO) drug development are complex and span from the discovery phase to late-…
Apr 30th • 12 mins read
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
clinical pharmacology, FDA reviews, PMR, PMC, molecular entitites, anticancer drug development
The article discusses optimizing oncology drug development, focusing on the impact of pharmacokinetic factors like food effects and drug interactions. It recommends early evaluation of these factors to enhance dosing accuracy and patient compliance. Advanced modeling and simulation are suggested to …
Mar 11th • 15 mins read
Mariam A. Ahmed, Chirag Patel, Nicole Drezner, Whitney Helms, Weiwei Tan, Daria Stypinski
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development
drug development, healthy, volunteers, oncology clinical trial
The content discusses the challenges and opportunities in conducting oncology clinical trials, particularly focusing on trials involving normal healthy volunteers (NHVs) and patients with cancer. There are over 5,000 ongoing oncology trials in the U.S., with low enrollment rates among adult c…
Oct 31st • 20 mins read
Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
FDA labeling format, PLR format, oncology drugs, FDA
The FDA conducts independent reviews of scientific data to ensure the safety and efficacy of investigational drug products. FDA-approved product labeling is a highly trusted source of information for approved drug use. FDA approval is only the beginning of a drug's lifecycle, with ongoing c…
Feb 15th • 13 mins read
Yan Ji, Jin Y. Jin, David M. Hyman, Geoffrey Kim and Ajit Suri
Challenges and Opportunities in Dose Finding in Oncology and Immuno-oncology
Focus on optimizing oncology therapeutics through quantitative translational and clinical pharmacology. Emphasis on dosage precision to maximize patient benefit. Challenges include confounding factors in exposure-response (ER) analysis, particularly for biologics. Necessity for multifacete…
Jul 11th • 10 mins read