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Statistical Challenges in the Analyses of Bone Mineral Density in Pediatric Populations
This article highlights several potential problems in the calculation of the Z-score: (1) reference data are manufacturer dependent; (2) a transformation is recommended to reduce the skewness often seen in BMD data, however a transformation parameter is only available in some references using the Hologic manufacturer; (3) some reference data may be obsolete, as they were done under older scan models; (4) reference data are recommended to be interpolated to the subject’s age, and linear interpolation is questionable; (5) reference data do not exist for all age groups; (6) reference data depend on the race of the subje...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Dinh, P. Tags: Special Populations Source Type: research

An Evaluation of the Efficiency of the Gulf Cooperation Council's Centralized Procedure by the Gulf Regulatory Authorities and Pharmaceutical Companies: Recommendations for an Improved Model
The aim of this study was to examine the views and experiences of the Gulf Cooperation Council (GCC) states and pharmaceutical companies to identify the strengths and weaknesses of the GCC centralized registration procedure (GCC-CP). Results of a questionnaire designed for the study and completed by GCC regulatory authorities and pharmaceutical companies who registered products through the GCC-CP showed that it is an effective system. However, it demonstrated that there is room for improvement. For example, provision of clear guidelines, transparency of procedures, effective interactions between authorities and companies, ...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Al-Rubaie, M. H., Salek, S., Walker, S. Tags: Global Perspectives Source Type: research

An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and Clinical Development Conditions
Conclusion: With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Sawicki-Wrzask, D., Thomsen, M., Bjerrum, O. J. Tags: Global Perspectives Source Type: research

Assessment of the e-Answers Initiative, a New Model for Response by Email to Scientific Information Requests Carried Out by the Medical Information Service of Novartis Pharmaceuticals in Spain: Results of an Internal Satisfaction Survey
Conclusion: In this anonymous survey with high participation of service users, the e-Answers initiative was evaluated positively. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Amat, C., Sarycheva, A., Rodellas, C., Diaz-Fort, A., Berge, E. Tags: Global Perspectives Source Type: research

What Defines Good Quality in a Clinical Study Report?
This study set out to identify the elements that contribute to the overall quality of clinical study reports using guided interactive introspection in a medical writing group (N = 28). All medical writers had a science background with a PhD; their professional experience ranged from 1 to 17 years (mean: 3.3 years). In total, 16 quality items were determined, which were grouped into 5 major areas: language, document structure, numerical information, audience focus, and company context. Ordered by decreasing importance, the 10 most important elements were: correctness, completeness, regulatory compliance, clarity of structur...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Schindler, T. M. Tags: Clinical Trials Source Type: research

Current Trends in Personalized Medicine and Companion Diagnostics: A Summary From the DIA Meeting on Personalized Medicine and Companion Diagnostics
Personalized medicine has reached the mainstream, accounting for more new drug approvals and a promising pipeline of candidate therapeutics. Recent advances in genomics, computational biology, medical imaging, diagnostic technologies, and translational medicine are creating the possibility for scientists to develop diagnostic tools and new treatments for cancer, genetic disorders, and infectious diseases that may be particularly effective in biomarker-defined subpopulations. Drug development under this model creates new challenges that will require the need for increased regulatory flexibility, novel clinical trial designs...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Tsourounis, M., Stuart, J., Pignato, W., Toscani, M., Barone, J. Tags: Product Development and Innovation Source Type: research

A Method of Addressing Proprietary Name Similarity for US Prescription Drugs
This article describes a series of tools created for regulatory reviewers to enhance the review of proprietary names under current federal regulations, with the goal of encouraging further innovation toward the goal of medication safety. These tools include measures of orthographic, phonetic, and semantic similarities and are designed be used together with the existing computerized measures of similarity. It is the hope that highlighting the importance of medication error reporting for the safety review process will further encourage health care professionals to provide adequate and detailed reporting regarding medication ...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Stockbridge, M. D., Taylor, K. Tags: Product Safety Source Type: research

Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management
Background: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to pote...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Slomiany, M., Bitar, R., Kruse, S., Jeffers, S., Berkowitz, K., Hassan, M. Tags: Product Safety Source Type: research

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms
Detection of off-target cardiovascular (CV) effects remains a significant challenge to drug development. Documentation of CV events in non-CV trials is often inadequate to interpret imbalances between treatment arms, which may lead to concerns about potential CV safety "signals." The Cardiac Safety Research Consortium (CSRC) public-private partnership has developed CV case report forms (CRFs) for adverse CV events, including death. These CRFs are intended to encourage collection, as near to the occurrence of an event as possible, of the minimum information necessary to assess, or possibly adjudicate, the event. A broad ran...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Sabol, M. E., Finkle, J., Krucoff, M., Stockbridge, N., Parkhill, N., Shinagawa, K., Mahaffey, K., Tcheng, J., Lenihan, D., Melloni, C., Todaro, T., Michelson, E., Munley, J., Zander, J., Oh, R. Tags: Product Safety Source Type: research

A Descriptive Evaluation of Prescriber Perceptions and Experience With Risk Evaluation and Mitigation Strategy (REMS) Programs in an Integrated Health Care System
Conclusion: The results from the survey suggest that prescriber specialty has an impact on the perceived value of the REMS program and the perceived need to counsel patients regarding medications with REMS programs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Rashid, N., Cheetham, T. C., Aranda, G., Guerrero, V. N., Bartell, H., Coghlan, R. J. Tags: Product Safety Source Type: research

Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study
Conclusions: The study findings suggest that, for simple drug information, adding absolute frequencies and percentages to direct-to-consumer advertisements may benefit consumers. Absolute differences and qualitative labels may not be needed. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Sullivan, H. W., O'Donoghue, A. C., Aikin, K. J. Tags: Policy Source Type: research

APEC Workshop Report of Good Review Practices on Medical Products
As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC), the Taiwan Food and Drug Administration (TFDA) organized 2 workshops. The purpose of these workshops was to address the fundamental elements of a well-designed regulatory review system, to provide complementary modules for GRevP and approaches to the exchange and the use of product assessment reports between regulatory authorities, and to further promote regulatory efficiencies and best practices. The workshops brough...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Lin, H.-Y., Chen, S. J.-Y., Gau, C.-S., Liu, L.-L. Tags: Regulatory Science Source Type: research

Monitoring and Evaluating the Effect of Regulatory Action: Some Recent Case Studies
Large electronic health care databases can be used to evaluate the effectiveness of regulatory action. Designing and interpreting such studies can be challenging. We demonstrate using case studies on modafinil, benzodiazepines, dosulepin, and piroxicam that measuring the impact of regulatory action is possible and can be beneficial, particularly in determining the need for further action or communication. For each case study, we discuss difficulties that may arise when measuring the effectiveness of regulatory action, which include but are not limited to: the choice of denominator, changes in the patient population, the av...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Thomson, A., Meeraus, W. H., Wong, J., Suvarna, R. Tags: Regulatory Science Source Type: research

How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative Examples
Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with the goal of improving translation of advances in emerging sciences to the development of safe and effective medical products. Since 2011, the research of FDA’s Center for Drug Evaluation and Research (CDER), including the work supported by the Critical Path Initiative, has been guided by the regulatory science needs identified in the CDER science and research needs report. In this review, the authors highlight a few of CDER’S Critical Path Initiative research projects, each addr...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Geanacopoulos, M., Barratt, R. Tags: Regulatory Science Source Type: research

Multifaceted Paths Toward Advancing Regulatory Science
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research