Therapeutic Innovation and Regulatory Science This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Treatment Outcomes of Nevirapine- Versus Efavirenz-Based Highly Active Antiretroviral Therapy Regimens Among Antiretroviral-Naive Adult Patients in Ethiopia: A Cohort Study
Conclusion: Although the finding of retrospective study should be interpreted with caution, efavirenz-based regimens were associated with superior treatment outcome. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Kedir, M. S., Gemeda, D. H., Suleman, S. Tags: Global Perspectives Source Type: research

Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products
Conclusions: This analysis showed the importance of early communication with FDA during development, and small companies with limited regulatory experience may gain the greatest benefit from early communication with FDA. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Vu, H. H., Pariser, A. R. Tags: Regulatory Science Source Type: research

Benefit-Risk Evaluation and Decision Making: Some Practical Insights
Pharmaceutical drugs and devices are increasingly evaluated by quantitative tools that combine benefit and risk. These tools vary by their limitations and desirable properties, which may confuse the decision-making process. Experts from the Food and Drug Administration (FDA) and industry shared their perspectives at the 2012 American Statistical Association (ASA) Biopharmaceutical Section FDA-Industry Statistics Workshop, and these insights are presented here. First, benefit-risk terminology is given to better understand subtle distinctions. Next, pragmatic considerations in endpoint selection are given that distinguish be...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Colopy, M. W., Damaraju, C. V., He, W., Jiang, Q., Levitan, B. S., Ruan, S., Yuan, Z. Tags: Product Development and Innovation Source Type: research

The Life Sciences Translational Challenge: The European Perspective
This article analyzes these issues in the context of European biopharmaceutical innovation, describes the actions that Europe is already taking, and suggests what more needs to be done. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Barker, R. W., Scannell, J. W. Tags: Product Development and Innovation Source Type: research

Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose Selection
Conclusions: For highly variable clinical endpoints, the fastest path should be to demonstrate PoC by biomarkers and then go directly to Ph2b to measure the target clinical endpoint. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Musser, B., Bolognese, J., Fayad, G. N., Bhattacharyya, J., Shentu, Y., Ederveen, A., Mixson, L., Patel, N. Tags: Clinical Trials Source Type: research

Choosing Appropriate Metrics to Evaluate Adverse Events in Safety Evaluation
This article reviews the common metrics and provides some recommendations. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Zhou, Y., Ke, C., Jiang, Q., Shahin, S., Snapinn, S. Tags: Product Safety Source Type: research

Lessons Learned From Hundreds of Thorough QT Studies
Conclusions: In exploring whether a thorough QT (TQT) study may be needed, we recommend that the relationship analysis between QTc and drug plasma concentration be performed when proper single ascending dose (SAD) and multiple ascending dose (MAD) studies are available. If the relationship cannot be detected and the 90% upper confidence interval at a fixed concentration level (50th or 75th percentile, or mean peak plasma concentration [Cmax]) is below a certain threshold level (eg, 10 milliseconds), then a TQT study might be unnecessary. If the relationship can be established and the 90% lower confidence interval at a fixe...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Zhang, J., Chen, H., Tsong, Y., Stockbridge, N. Tags: Product Safety Source Type: research

Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the "Like"
Conclusion: In a descriptive review of the social media posts analyzed, this study found pharmaceutical company posts to relate to disease state awareness, business updates, and community outreach projects. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Jackson, W., Park, B., Toscani, M., Hermes-DeSantis, E. Tags: Policy Source Type: research

Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD
Conclusions: The results provide insights into potential revisions to the medication guides that may improve reading behaviors. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Bibeau, K. B., DiSantostefano, R. L., Hinds, D. Tags: Policy Source Type: research

Focus on Health Literacy: Recommendations to Improve European Union Risk Management Plan Public Summaries
Conclusions: The authors recommend that stakeholders reassess the intended use of the document by members of the public and rethink its scope and structure, with close involvement of patients and caregivers. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Wolka, A., Simpson, K., Lockwood, K., Neuhauser, L. Tags: Policy Source Type: research

Improving the Legitimacy of Medicines Funding Decisions: A Critical Literature Review
Many health care systems globally provide publicly subsidized access to prescribed medicines. Decisions about which medicines to fund affect a range of stakeholders, and it is not reasonable to expect that medicines funding decisions are supported by all stakeholder groups all the time. A more realistic aim may be for decisions to be understood and accepted as legitimate by stakeholders; however, several shortcomings of existing processes make it difficult to achieve this aim. To date, the main strategy to address these shortcomings has been to increase stakeholder involvement in decision making, either by eliciting stakeh...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Pace, J., Pearson, S.-A., Lipworth, W. Tags: Ethics Special Section Source Type: research

Off-Label Promotion of Prescription Medicine: Is It Ever Justifiable?
Off-label promotion has attracted intense scrutiny from regulators in recent decades, resulting in many pharmaceutical companies paying hefty penalties for illegal marketing practices. At the same time, the pharmaceutical industry has accused governments of applying double standards by encouraging the use of cheaper off-label alternatives to registered treatments, and defended their "right" to promote off-label drugs on freedom of speech grounds. However, the debate about off-label promotion and the prescribing that results has largely failed to address the issue that really matters—what impact does off-label promoti...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Ghinea, N., Lipworth, W., Kerridge, I. Tags: Ethics Special Section Source Type: research

Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors
Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Although an EAP is a regulated program, the decision to authorize an EAP is the responsibility of the biopharmaceutical sponsor. Because of the significant impact an EAP can have on current patients, drug development, and future patients,...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Klopfenstein, M., Van Campen, L. E., Garnett, T. Tags: Ethics Special Section Source Type: research

The Ethics Around Drug Labels and Generic Medicines
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Day, R., Lipworth, W., Ghinea, N. Tags: Ethics Special Section Source Type: research

Ethical Considerations for Increased Transparency and Reproducibility in the Retrospective Analysis of Health Care Data
In the field of health care, researchers and decision makers are increasingly turning toward retrospective observational studies of administrative claims and electronic health record databases to improve outcomes for patients. For many important questions, randomized studies have not been conducted, and even when they have been, such studies often inadequately reflect the realities of patients’ lives or care. However, use of retrospective studies not only increases methodological complexity but also requires more subjectivity for those attempting to perform statistical analysis. The hurdles for establishing the repro...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Rotelli, M. D. Tags: Ethics Special Section Source Type: research