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Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First Approval
Conclusions: Selective data collection should be adopted in cases in which the additional indication of a drug is for the same tumor type and usage as the first or previous indication. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Sekine, N., Ohashi, Y., Aruga, A. Tags: Product Safety Source Type: research

Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance
Conclusion: The higher quality ICSRs aids in more effective identification of new drug safety alerts and provides evidence-based information for regulating the drug safety. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Kumar, R., Kumar, P., Kalaiselvan, V., Kaur, I., Singh, G. N. Tags: Product Safety Source Type: research

Reporting Adverse Drug Reactions in Product Labels
Product labels are intended to provide health care professionals with clear and concise prescribing information that will enhance the safe and effective use of drug products. In this manuscript, we offer suggestions to improve product labels. First, we recommend that product labels that include comparator data be changed to include adjusted incidence proportions (or adjusted incidence rates when needed and appropriate) for adverse drug reactions that are somewhat common. Second, we believe that including comparator incidence in product labels is a good practice, as it gives health care providers and patients appropriate in...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Crowe, B., Chuang-Stein, C., Lettis, S., Brueckner, A. Tags: Product Safety Source Type: research

An Overview of the Regulatory and Developmental Strategies of Chronotherapeutics
The pivotal idea toward the development of chronotherapeutics is synchronizing the in vivo drug bioavailability with the rhythms of the disease to optimize therapeutic outcomes and minimize side effects, which is contrary to the homeostatic theory of drug delivery. The advent of formulation technologies, marketing exclusivities of innovative products, and provisions/amendments in regulatory frameworks have led to the development of commercial chronotherapeutic products, but their numbers are few and are confined mainly to diseases of the cardiovascular system. A major bottleneck for its development would be the understandi...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Mirza, M. A., Shakeel, F., Iqbal, Z. Tags: Clinical Trials Source Type: research

Mobile Nurse Services in Clinical Trials: Usage and Industry Perceptions
Conclusions: Building effective partnerships with 1 to 2 vendors is considered a key factor for long-term success. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Stergiopoulos, S., Eustace, C., Stem, K., Getz, K. A. Tags: Clinical Trials Source Type: research

The Impact of Protocol Amendments on Clinical Trial Performance and Cost
Conclusions: The study findings provide insights into optimizing development planning, protocol design, and clinical trial management practices. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Getz, K. A., Stergiopoulos, S., Short, M., Surgeon, L., Krauss, R., Pretorius, S., Desmond, J., Dunn, D. Tags: Clinical Trials Source Type: research

Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label
Conclusions: Most participants seemed to prefer the US Drug Facts label, partly because of its perceived completeness. These findings suggest further improvements for the proposed MIB as a step toward Australian OTC label standardization. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Tong, V., Raynor, D. K., Hamrosi, K. K., Acharya, B., Panchal, N., Aslani, P. Tags: Global Perspectives Source Type: research

Use of Medical Mobile Applications Among Hospital Pharmacists in Malaysia
Conclusions: The use of HHCs for DI among pharmacists in Malaysia was high. The use of locally produced DI sources is still low compared to overseas sources. The most popular applications used for drug-related medical information were Micromedex, followed by Lexicomp and Medscape. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Ming, L. C., Hameed, M. A., Lee, D. D., Apidi, N. A., Lai, P. S. M., Hadi, M. A., Al-Worafi, Y. M. A., Khan, T. M. Tags: Global Perspectives Source Type: research

Regulatory System Changes in Russia: A Historical Review and Future Perspectives
The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are ...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Lozda, R. Tags: Global Perspectives Source Type: research

TransCelerates Clinical Quality Management System: From a Vision to a Conceptual Framework
This article chronicles the evolution of a TransCelerate concept paper describing a proposed clinical QMS framework and reviews feedback from varied global clinical trial stakeholders during socialization of the concept paper. Many stakeholders recognized the potential for the concept paper to inform development of a harmonized International Council for Harmonisation (ICH) guideline, providing needed clarity from regulators on their expectations for QMS in the clinical realm. Accordingly, the article also describes TransCelerate’s efforts to work with regulators to facilitate harmonization on this important topic and...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Meeker-OConnell, A., Sam, L. M., Bergamo, N., Little, J. A. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

Maintaining the Highest Ethical Standard in Publishing
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

Statistical Considerations for an Adaptive Design for a Serious Rare Disease
Conclusions: The N-MOmentum study minimizes exposure to placebo for individual patients. The application of several statistical methods in the N-MOmentum trial is novel in NMOSD and aims to achieve a balance between minimizing risk and maintaining scientific integrity. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Patra, K., Cree, B. A. C., Katz, E., Pulkstenis, E., Dmitrienko, A., Cutter, G. Tags: Statistics Source Type: research

Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach
Conclusions: It is important to explain the scientific rationale for the control strategy, design space, and real-time release in the QOS and how "regulatory flexibility" is expressed in the AF. The QOS checklist enables applicants to prepare an appropriately detailed QOS that should satisfy the PMDA’s critical review points. The following are recommended for further discussion topics to enable efficient and consistent review by the PMDA for QbD products: (1) Clear guidance on how to express "regulatory flexibility" in the AF and (2) a "QOS checklist for QbD products" that is agreed upon by both regulatory agencies a...
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Kuno, K., Toyoshima, S. Tags: Global Perspectives Source Type: research

Pharmaceutical Pricing and Reimbursement in Japan: For Faster, More Complete Access to New Drugs
Conclusions: From the view of NHI coverage scope and speed, the hurdle to access new drugs in Japan is shown to be lower than in other countries that also set public prices for reimbursement. Although the difficulty of controlling health expenditures increases, drug pricing that properly reflects the drug’s clinical value is important in that it also furthers the development of medical technology. Better price setting can also facilitate patient access to innovative drugs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Takayama, A., Narukawa, M. Tags: Global Perspectives Source Type: research

Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting Database
Conclusions: The number of reports of renal adverse events were highest in male patients 60 to 69 years of age treated with telaprevir. In addition, our findings suggested that anorexia is correlated with renal adverse events after telaprevir treatment. Further investigation is required to clarify the mechanism of renal impairments during triple therapy. Such knowledge might improve the safety of telaprevir therapy. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Ichida, A., Motohashi, H., Kitano, A., Takayama, A., Inui, K.-i., Yano, Y. Tags: Global Perspectives Source Type: research