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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
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Therapeutic Innovation & Regulatory Science
Journal Prestige (SJR): 0.726
Citation Impact (citeScore): 1
Number of Followers: 7  
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 2168-4790 - ISSN (Online) 2168-4804
Published by Sage Publications Homepage  [1175 journals]
  • In Vitro Skin Permeation Methodology for Over-The-Counter Topical
           Dermatologic Products

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      Authors: Luke Oh, Sojeong Yi, Da Zhang, Soo Hyeon Shin, Edward Bashaw
      Abstract: Therapeutic Innovation & Regulatory Science, Ahead of Print.
      For topically applied over-the-counter (OTC) products, the association of unwanted systemic exposure and adverse events may be difficult to ascertain without a recognition or determination of in vivo absorption. Evaluation of skin permeability using a validated in vitro permeation methodology can provide important information for both initial formulation selection and reformulation during the product life cycle. Additionally, a comparison of permeation rates between formulations using a validated methodology could reduce the number of nonclinical studies needed as part of reformulation. However, many in vitro permeation tests (IVPTs) have produced results with high variability and low reproducibility between study sites. It is unclear if this is due to a lack of a standardized protocol, or lack of control of multiple key experimental factors including skin source, preparation, receptor fluid, and study design. This review presents the authors perspective on the potential regulatory utility of IVPT and proposes steps to improve the accuracy and reproducibility of IVPT. The focus of this review is on topical dermatologic drugs with an initial emphasis on the OTC marketplace where reformulations are more common.
      Citation: Therapeutic Innovation & Regulatory Science
      DOI: 10.1177/2168479019875338
  • Patient Feedback on a Warfarin Action Plan Used in a Local Australian
           Physician Practice Setting

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      Authors: Angela W.P. Yiu, Vincent W. Lee, Kingsley K. Ng, Beata V. Bajorek
      Abstract: Therapeutic Innovation & Regulatory Science, Ahead of Print.
      Background:Warfarin is a high-risk medicine, and older persons (those aged 65 years and older)1,2 who take this therapy need medicines information about it that is at a level which is both understandable and comprehensive to improve their knowledge about the risks and benefits of warfarin therapy.3,4 Therefore, the primary objective of this study was to report patient feedback on a Warfarin Action Plan (WAP) (leaflet) and identify patients’ preferences regarding its content and format. The secondary objective was to canvass in-depth feedback regarding the participants’ information needs and current information-seeking practices with respect to warfarin therapy.Method:In an Australian General Practice medical centre setting, a qualitative study comprising 34 individual interviews was conducted. Emergent themes were elicited via a qualitative analysis using manual inductive coding.Results:The majority of participants gave very positive feedback on the WAP leaflet, stating that it was a useful and concise resource. In canvasing this feedback, 4 themes emerged: (1) the need for information about warfarin therapy, (2) reliance on doctors and/or pharmacists for information, (3) the need for information to normalize their daily life, and (4) patients and carers acting on the new information.Conclusion:The WAP is a simple and well-received tool that meets the knowledge and education needs about warfarin therapy for older people and their carers.
      Citation: Therapeutic Innovation & Regulatory Science
      DOI: 10.1177/2168479019865900
  • Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for
           a Reasonable Drug-Pricing Policy

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      Authors: Shoyo Shibata, Daigo Fukumoto, Takeshi Suzuki, Koken Ozaki
      Abstract: Therapeutic Innovation & Regulatory Science, Ahead of Print.
      Background:Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies—the cost calculation method— refers extensively to the prediction of drug sales in establishing drug prices. Deviations from predicted sales can induce disproportionate drug prices and unexpected pharmaceutical expenditures. This study aimed to estimate the upward deviation of actual sales from predicted sales and to explore the predictors of such upward deviation.Methods:Estimates of upward deviation in 2015 were produced for new molecular entities (NMEs) approved in 2006-2015. To identify the predictors associated with upward deviation through binary logistic regression analyses, sales within 3 years of launch and in the predicted year in which peak sales would be reached were used.Results:Estimated upward deviation was more than 1220 billion yen in 2015 for the targeted drugs. Drugs priced by the cost calculation method or by obtaining additional indications were significantly more likely to show an upward deviation from predicted peak sales.Conclusion:There is substantial upward deviation between actual and predicted drug sales in Japan. So long as drug sales predictions are used in drug price calculations, a flexible repricing system is needed to buffer unexpected pharmaceutical expenditures.
      Citation: Therapeutic Innovation & Regulatory Science
      DOI: 10.1177/2168479019860123
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