Christy S. John

Into the Unknown: Regulatory Perspective on Identifying Optimized Dosages of Oncology Radiopharmaceutical Therapies

William F. Maguire, Donika Plyku, Sundeep Agrawal, Anthony Fotenos et autres

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FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA -Mutated Metastatic Castration-Resistant Prostate Cancer

Jaleh Fallah, Jianjin Xu, Chana Weinstock, Michael H. Brave et autres

PURPOSE This article summarizes the US Food and Drug Administration (FDA) review of the data leading to approval of olaparib plus abiraterone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated ( BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined …

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Effect of a Sensorimotor Exercise Regime for Upper Limb Deficits in the In-Hospital Phase After a Supratentorial Stroke (SMULS)—Protocol for a Randomized Controlled Trial

Dorcas B.C. Gandhi, Nistara S. Chawla, Christy S. John, Amarjot Gill Singh et autres

Background Somatosensory impairments in the upper limb are a common occurrence in >50% of post-stroke individuals. The effects of a combined sensorimotor therapy program on improving functional outcomes have not been studied extensively especially in the acute and subacute phase post-stroke. Methods …

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FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer

Jaleh Fallah, Sundeep Agrawal, Haley Gittleman, Mallorie H. Fiero et autres

On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition …

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FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

Kelly J. Norsworthy, Chia‐Wen Ko, Jee Eun Lee, Jiang Liu et autres

Abstract On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older. GO …

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Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans – a practical guide

Tal Burt, Christy S. John, Jon Ruckle, Le T. Vuong

INTRODUCTION: Phase-0 studies, including microdosing, also called Exploratory Investigational New Drug (eIND) or exploratory clinical trials, are a regulatory framework for first-in-human (FIH) trials. Common to these approaches is the use and implied safety of limited exposures to test articles. Use of …

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Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development

Tal Burt, Kenta Yoshida, Graham Lappin, Le T. Vuong et autres

A number of drivers and developments suggest that microdosing and other phase 0 applications will experience increased utilization in the near-to-medium future. Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities …

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Gender-dependent differences in the efficacy and safety of Boceprevir triple therapy in German real-life

Peter Buggisch, H Löhr, G Teuber, H Steffens et autres

Background: Since 2011, triple therapy with the HCV protease inhibitor boceprevir (BOC) is widely used as standard of care for patients (pts) with chronic HCV G1 infection. Until now, there is limited information about the efficacy and safety of BOC triple therapy …

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Keys to success with clinical trials.

Seymour Katz, Heather Dufficy, Christy S. John

Since clinical trials provide access to novel therapies years before they become available on the open market, some physicians may be curious about participating in the clinical trial process. Indeed, becoming a clinical trial investigator can positively impact a private practice in …

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Imaging the Function of P-Glycoprotein With Radiotracers: Pharmacokinetics and In Vivo Applications

Pavitra Kannan, Christy S. John, Sami S. Zoghbi, Christer Halldin et autres

P-glycoprotein (P-gp), an efflux transporter, controls the pharmacokinetics of various compounds under physiological conditions. P-gp-mediated drug efflux has been suggested as playing a role in various disorders, including multidrug-resistant cancer and medication-refractory epilepsy. However, P-gp inhibition has had, to date, little or …

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Can [F-18]FDG PET imaging predict early response to chemotherapy in breast cancer patients?

Christy S. John, Rajanikanth Madabushi, Camile S. Farah, Cezary Lubas et autres

e14577 Background: The purpose of this study was to perform a meta-analysis of literature data and see if [F-18]FDG and PET imaging can be used to predict the early response to chemotherapy based upon the measure of standard uptake value (SUV) or …

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Genetic and Epigenetic Biomarkers in Cancer

Mukesh Verma, Daniela Seminara, Fernando Arena, Christy S. John et autres

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