Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · May 2014
Randomized Controlled Trial Comparative StudyExposure-response relationship of T-DM1: insight into dose optimization for patients with HER2-positive metastatic breast cancer.
Exposure-response (E-R) analyses for ado-trastuzumab emtansine (T-DM1, Kadcyla) were performed using data from a randomized, active control (lapatinib plus capecitabine) trial in patients with human epidermal growth factor 2-positive metastatic breast cancer. Kaplan-Meier survival analyses stratified by T-DM1 trough concentration on day 21 of cycle 1 (Cmin,C1D21) were performed for overall survival (OS) and progression-free survival (PFS). ⋯ The percentage of patients who received T-DM1 dose adjustments was similar across the exposure range and was lower than that of the active control arm. Our findings suggest that there may be an opportunity to optimize Kadcyla dose in the patient subgroup with low T-DM1 exposure for improved efficacy with acceptable tolerability.
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Clin. Pharmacol. Ther. · May 2014
Drug development in serious diseases: the new "breakthrough therapy" designation.
The US Food and Drug Administration Safety and Innovation Act (FDASIA) was signed on 9 July 2012. This law created a new "breakthrough therapy" (BT) designation program for investigational drugs and biologics intended to treat a serious disease and having "preliminary clinical evidence [that] indicates that the drug may demonstrate substantial clinical improvement over existing therapies on one or more clinically significant endpoints."(1) Many questions have been posed about the impact of this new program on drug development.
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Clin. Pharmacol. Ther. · May 2014
Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics.
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics.
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In Her, the award-winning motion picture written and directed by Spike Jonze, the lead character played by Joaquin Phoenix falls hopelessly in love with an operating system deployed on his many devices, including his mobile telephone. Although the health-care sector has not yet attained that "magic moment" with mobile devices and their applications, there appears to be quite a lot for those in the field to like.
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Clin. Pharmacol. Ther. · May 2014
Promise and challenges with the use of mobile applications to support and improve patient care: an industry perspective.
Mobile applications represent an immense opportunity to support and improve patient health care, as the scope and functionality of medical apps are enabling physicians and patients to manage care in new, fast, and personalized ways. Several challenges exist in medical-app development, including careful attention to quality systems, medical-device regulation, and app life span. Despite these complexities, we find that development of mobile medical apps is a worthwhile undertaking given their potential to improve outcomes for patients.