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Therapeutic Innovation & Regulatory Science
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0.90
Papers
817
Papers 817
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Although checklists and guidelines for reporting and interpretation of clinical trial results are of immense value there is still room for a biased presentation in journal publications. Two importa...
#1Sashka Hristoskova (Novartis)H-Index: 2
#2James Milligan (AstraZeneca)H-Index: 1
Last.Robyn Rennick (GSK: GlaxoSmithKline)
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The approach used by medical information services in answering unsolicited safety-related questions from health care professionals regarding prescription medicines varies widely across the pharmace...
Background:“Patient experience data” (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment tradi...
#1Haruka Nakada JdH-Index: 5
#2Yusuke Inoue (UTokyo: University of Tokyo)H-Index: 4
view all 6 authors...
Objective:The objective of this study is to assess public attitudes toward pharmaceutical companies’ secondary uses of patient records and public preferences regarding consent approaches.Method:300...
#1Luke Oh (CDER: Center for Drug Evaluation and Research)H-Index: 1
#2Sojeong Yi (CDER: Center for Drug Evaluation and Research)
Last.Edward Bashaw (CDER: Center for Drug Evaluation and Research)H-Index: 2
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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 vi...
#1Russell Reeve (Durham University)H-Index: 1
#2Klaus Gottlieb (Eli Lilly and Company)H-Index: 1
Background:Cohen's kappa is a statistic that estimates interobserver agreement. It was originally introduced to help develop diagnostic tests. Interpretative readings of 2 observers, for example, o...
#1Abhishek Singh (Ministry of Health and Family Welfare)
#2M. Kalaivani (Ministry of Health and Family Welfare)H-Index: 1
Last.Suresh Kumar GuptaH-Index: 29
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Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. P...
When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial evidence of effectiveness? The answer to this question, partic...
#1Elena Tomaselli Muensterman (Takeda Pharmaceutical Company)
#2Yijia Luo (Takeda Pharmaceutical Company)
Last.Jonathon M. Parker (Takeda Pharmaceutical Company)
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Background:Because of the increasing demand for drugs addressing life-threatening and rare diseases, regulatory agencies have developed a variety of accelerated regulatory pathways. These programs ...
Background:Older age plays an important role in pharmaceutical benefit-risk perception. This creates challenges and opportunities, especially for regulatory authorities and advocacy groups seeking ...
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