Mark J. Ratain
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View article: Strengthening the Food and Drug Administration Office of Clinical Pharmacology's Labeling Authority
Strengthening the Food and Drug Administration Office of Clinical Pharmacology's Labeling Authority Open
Optimal prescribing of drug products requires accurate informative drug labels. One critical aspect of a label is the recommended dosage. We suggest that the final authority for this portion of the label should reside in FDA's Office of Cl…
View article: Results of the <scp>ACCOuNT</scp> Trial: A Multi‐Institutional Prospective Pharmacogenomics Implementation Trial for African American Inpatients
Results of the <span>ACCOuNT</span> Trial: A Multi‐Institutional Prospective Pharmacogenomics Implementation Trial for African American Inpatients Open
Pharmacogenomics implementation efforts have increased over the last decade, but no published prospective pharmacogenomics trials have formally evaluated utility in underrepresented populations. We present final results from the ACCOuNT tr…
View article: Impact of First‐of‐Its‐Kind Patient‐Facing Pharmacogenetics Tool on Dosing Decisions and Treatment Outcomes
Impact of First‐of‐Its‐Kind Patient‐Facing Pharmacogenetics Tool on Dosing Decisions and Treatment Outcomes Open
Germline pharmacogenetics (PGx) is increasingly used to tailor medication selection/dosing. However, existing systems primarily communicate PGx results to providers, limiting direct patient engagement. To address this, we developed YourPGx…
View article: Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs
Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs Open
Ongoing efforts to optimize the dosages of oncology drugs have largely focused on the initial indication, with emphasis placed on maximizing the utility of all available evidence to improve dose finding, dose selection, and trial design; h…
View article: Triaging acute chest syndrome clinical decision-making using bedside SaO2/FiO2 ratio
Triaging acute chest syndrome clinical decision-making using bedside SaO2/FiO2 ratio Open
Acute chest syndrome (ACS) severity is inconsistently defined, and its clinical course is difficult to predict. This retrospective observational study evaluated the utility of the ratio of pulse oximetry oxygen saturation (SaO2) to the fra…
View article: Care Team Attributes Predict Likelihood of Utilizing Pharmacogenomic Information During Inpatient Prescribing
Care Team Attributes Predict Likelihood of Utilizing Pharmacogenomic Information During Inpatient Prescribing Open
Medication prescribing is imperfect, and unintended side effects complicate patient care. Pharmacogenomics (PGx) is an emerging solution that associates genotypes with personalized drug‐related outcomes, but it has not been widely adopted.…
View article: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment (C-PAIN): A Randomized Trial of Preemptive CYP2D6 Genotyping in Cancer Palliative Care
Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment (C-PAIN): A Randomized Trial of Preemptive CYP2D6 Genotyping in Cancer Palliative Care Open
The primary study outcome will be composite pain intensity during the first 45 days after an index opioid prescription for codeine, tramadol, or hydrocodone. Safety will be assessed by comparing opioid-related adverse event rates between t…
View article: Weight-Based Dosing of Pembrolizumab Every 6 Weeks in the Time of COVID-19
Weight-Based Dosing of Pembrolizumab Every 6 Weeks in the Time of COVID-19 Open
This Viewpoint suggests a new dosage for pembrolizumab treatment that could decrease patients’ exposure risk to COVID-19.
View article: Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer Open
While therapeutic drug monitoring is a potentially attractive strategy that can be utilized by clinical pharmacologists to optimize drug dosing, the costs and risks must be balanced against the potential benefits. However, there is great u…
View article: Gene signatures derived from transcriptomic-causal networks stratified colorectal cancer patients for effective targeted therapy
Gene signatures derived from transcriptomic-causal networks stratified colorectal cancer patients for effective targeted therapy Open
Predictive and prognostic gene signatures derived from interconnectivity among genes can tailor clinical care to patients in cancer treatment. We identified gene interconnectivity as the transcriptomic-causal network by integrating germlin…
View article: An Ethical and Financial Obligation for Sickle Cell Disease Gene Therapy in the United States
An Ethical and Financial Obligation for Sickle Cell Disease Gene Therapy in the United States Open
Ideas and Opinions5 December 2023An Ethical and Financial Obligation for Sickle Cell Disease Gene Therapy in the United StatesAustin Wesevich, MD, MPH, Monica E. Peek, MD, MPH, MSc, and Mark J. Ratain, MDAustin Wesevich, MD, MPHSection of …
View article: Common variation in a long non-coding RNA gene modulates variation of circulating TGF-<i>β</i>2 levels in metastatic colorectal cancer patients (Alliance)
Common variation in a long non-coding RNA gene modulates variation of circulating TGF-<i>β</i>2 levels in metastatic colorectal cancer patients (Alliance) Open
Background Herein, we report results from a genome-wide study conducted to identify protein quantitative trait loci (pQTL) for circulating angiogenic and inflammatory protein markers in patients with metastatic colorectal cancer (mCRC).The…
View article: Project Optimus: Is the US Food and Drug Administration Waiving Dose Optimization for Orphan Drugs?
Project Optimus: Is the US Food and Drug Administration Waiving Dose Optimization for Orphan Drugs? Open
This Viewpoint discusses the US Food and Drug Administration’s Project Optimus, which focuses on new oncology drug dose optimization and examines concerns about the accelerated postmarketing approval of adjusted dosing of oncologic drugs.
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Alternative Trastuzumab Dosing Schedules Are Associated With Reductions in Health Care Greenhouse Gas Emissions
Alternative Trastuzumab Dosing Schedules Are Associated With Reductions in Health Care Greenhouse Gas Emissions Open
Cancer therapy has environmental costs. In this simulation analysis, @garthstrohbehn and colleagues show how less frequent dosing and shorter durations of therapy might improve public health without making patients with cancer worse off.
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Data from Identification of a Variant in <i>KDR</i> Associated with Serum VEGFR2 and Pharmacodynamics of Pazopanib
Data from Identification of a Variant in <i>KDR</i> Associated with Serum VEGFR2 and Pharmacodynamics of Pazopanib Open
Purpose: VEGF receptor (VEGFR) kinases are important drug targets in oncology that affect function of systemic endothelial cells. To discover genetic markers that affect VEGFR inhibitor pharmacodynamics, we performed a genome-wide associat…
View article: Supplementary Methods, Figures S1-S2, Table S1-S2 from Identification of a Variant in <i>KDR</i> Associated with Serum VEGFR2 and Pharmacodynamics of Pazopanib
Supplementary Methods, Figures S1-S2, Table S1-S2 from Identification of a Variant in <i>KDR</i> Associated with Serum VEGFR2 and Pharmacodynamics of Pazopanib Open
Materials and Methods Fig. S1. Linkage disequilibrium (LD) between rs725344 and SNPs from the IBC chip within KDR in the Old Order Amish. Fig. S2. Interspecies conservation of C482 in homologous sequences. Table S1. Candidate variants with…