Results for 'drug dose'
Karen Geary
Finding the Right Drug at the Right Dose the First Time: Has the Era of Personalized Formularies Finally Arrived?
drug dose, dose, pharmacogenomics, Personalized medicine
Many Americans take medications that are ineffective or cause adverse reactions due to genetic differences in drug metabolism. Pharmacogenomics, the study of how genes affect drug response, can help tailor medications to individual genetic profiles, reducing trial and error in prescriptions. A s…
Sep 27th • 1 min read
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development
Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…
Nov 20th • 12 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
Haiqing Isaac Dai, Yulia Vugmeyster, Naveen Mangal
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects
Complex E–R relationship, immuno-oncology, single-dose PK model, therapeutic monoclonal antibodies
Recent data from immuno-oncology clinical studies show that the exposure–response (E–R) relationship for therapeutic monoclonal antibodies (mAbs) is often confounded by various factors. The complex interplay involves patient characteristics, disease, drug exposure, clearance, and…
Jun 18th • 30 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
M. Ochoa de Olza, M. Oliva, C. Hierro I. Matos, J. Martin-Liberal, E. Garralda
Early-drug development in the era of immuno-oncology: are we ready to face the challenges?
immunotherapy, early-drug development, toxicology studies, dose determination
The classical development of drugs is being replaced by a seamless drug-development process. First-in-human trials now often include large expansion cohorts to quickly identify early signs of activity and achieve rapid regulatory approval. Intense competition among pharmaceutical companies and t…
Jun 26th • 26 mins read
Yafang Huanga, Weiyi Xiongb, Jingwei Zhaoa, Wentao Lia, Li Mac, Hao Wua
Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021
Early phase clinical trial, Dose-expansion cohort, Single-arm trial, Pivotal trial, FDA approved indications, Targeted anticancer drugs
Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021. 59.6% of indications were approved based on Early Phase Clinical Trials (EPCTs). There was a notable annual increase of 22.2% in approvals based on EPCTs, compared to a 5.0% increase for ph…
Mar 9th • 10 mins read
Michael Z. Liao, Dan Lu, Matts Kågedal, Dale Miles, Divya Samineni, Stephanie N. Liu, Chunze Li
Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?
antibody, antibody-drug conjugates, ADC's, FDA
ADCs (Antibody-Drug Conjugates) are a promising area in oncology drug development, improving the therapeutic window of potent, nonspecific payloads by conjugating them to antibodies. The FDA has approved nine ADCs for solid and hematological tumors, with several more showing promising clinical ac…
Apr 26th • 15 mins read
Yassine Kamal Lyauk, Daniël Martijn Jonker, Trine Meldgaard Lund
Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations
FDA, sequential clinical development, drug approvals, clinical trials, dosages
This review evaluates the current practice of dose finding in the pharmaceutical industry and assesses the clinical evidence supporting the optimality of the label dose. Previous work has focused on dose-ranging trial design, while clinical development paths and dose–exposure–res…
Jun 29th • 15 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
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
Garth W. Strohbehn, MD, MPhil, Allen S. Lichter, MD and Mark J. Ratain, MD
US Government Payer-Funded Trials to Address Oncology's Drug-Dosing Conundrum: A Congressional Call to Action?
ORF, NCTN, dosing, clinical trials, FDA
Since the mid-20th century, cancer drug development has been driven by the "more is better" assumption, seeking the maximum tolerated dose in early trials. The FDA's Oncology Center of Excellence (OCE) Project Optimus (2021) requires dose optimization for new oncology drugs, but this does not…
Feb 13th • 5 mins read
Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development
Quantitative Translation, Immuno-Oncology, Research, Development, CIC
Exploring the therapeutic potential of the rapidly expanding field of immuno-oncology (IO) drug targets and diverse therapeutic modalities. Recognizing the need for principled decisions based on biologically sound quantitative translation in a competitive clinical research environment. High…
Jul 9th • 3 mins read
Mateusz T. Wasylewski, Karolina Strzebonska, Magdalena Koperny, Maciej Polak, Jonathan Kimmelman, Marcin Waligora
Clinical development success rates and social value of pediatric Phase 1 trials in oncology
pediatric oncology, clinical development, trials, success rates
Pediatric Phase 1 trials in oncology aim to assess social value, focusing on rates of approval, transition to further phases, and citation in research. The study analyzed trials from 2004 to 2013, utilizing data from FDA, EMA, ClinicalTrials.gov, EU Clinical Trials Register, and Google Scholar. …
Jun 21st • 28 mins read
Timothy Qi, Tyler Dunlap, Yanguang Cao1
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
oncology, precision medicine, tumor evolution, dosing, FDA
Focus on tumor evolution, which leads to therapeutic failure and disease relapse. Emphasis on the effect of tumor evolution on the exposure-response (E-R) relationships of oncology drugs. Advocacy for prioritizing tumor evolution during clinical development to select optimal doses for targeted t…
Sep 2nd • 10 mins read
Sarah A. Weiss, MD, and Harriet Kluger, MD
CheckMate-067: Raising the Bar for the Next Decade in Oncology
checkmate-067, nivolumab, oncology, relativity-047
Historically, few effective systemic therapies were available for advanced melanoma, but recent advancements have led to significant progress. In 2015, the US FDA approved the combination of ipilimumab and nivolumab based on the results of the CheckMate-067 trial. CheckMate-067 demonstrated lo…
Dec 2nd • 2 mins read
Laleh Amiri-Kordestani & Richard Pazdur
Oncology approvals in 2020: a year of firsts in the midst of a pandemic
oncology approvals, pandemic, FDA, biosimilar, oncology, COVID-19
Despite the global COVID-19 pandemic, 2020 was an active year for the OCE. In 2021, the OCE is engaging in Project 2025, an effort to envision the next 5 years in oncology drug development and leverage our resources and talents to improve collaboration with stakeholders to move the field forward as …
Jan 29th • 4 mins read