abstract：:Confirmation of efficacy in pediatric drug development has traditionally required large, fully powered efficacy studies that have proven to have major feasibility and ethical challenges. Extrapolation of efficacy in the framework provided by the US Food and Drug Administration and European Medicines Agency is an appro...

journal_title：Therapeutic innovation & regulatory science

authors： Leil TA,Zee P,Suryawanshi S,Male C,Portman R

更新日期：2013-09-01 00:00:00

abstract：:There is a long history of discussions about what is a minimal clinically important difference (MCID) and how this term applies to clinical research. This paper deals with a practical framework for MCID and its applicability to clinical trials. A literature review on the topic confirmed the fundamental role of MCID fo...

journal_title：Therapeutic innovation & regulatory science

authors： Koynova D,Lühmann R,Fischer R

更新日期：2013-07-01 00:00:00

abstract：:The product pipeline for diseases that disproportionately affect the developing world has considerably expanded over the last decade. Indeed, there are about 134 products for these diseases in the pipeline, including vaccines, drugs, diagnostics, microbicides, and vector control tools, and dozens of these products are...

journal_title：Therapeutic innovation & regulatory science

authors： Saidu Y,De Angelis D,Aiolli S,Stefano G,Georges AM

更新日期：2013-05-01 00:00:00

abstract：:This study aimed to determine the potentially severe chemical properties of drugs that can cause adverse drug reactions (ADRs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) by using a data mining method. The study data were extracted from the Adverse Event Repor...

journal_title：Therapeutic innovation & regulatory science

authors： Shirakuni Y,Okamoto K,Uejima E,Inui S,Takahara JI,Ohgaru T,Yamasaki H,Tian Y,Kawashita N,Inoue R,Yasunaga T,Takagi T

更新日期：2013-03-01 00:00:00

abstract：:The QT interval is correlated with heart rate; therefore, the QT interval is usually corrected by heart rate when drug-induced QT effect is studied. Currently, there are many correction methods that use either fixed or data-driven approaches. The effectiveness of correction methods depends on many factors and varies f...

journal_title：Therapeutic innovation & regulatory science

authors： Dang Q,Zhang J

更新日期：2013-03-01 00:00:00

abstract：:Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices A...

journal_title：Therapeutic innovation & regulatory science

authors： Asahina Y,Tanaka A,Uyama Y,Kuramochi K,Maruyama H

更新日期：2013-01-01 00:00:00

abstract：:Since 1992 many changes have occurred in the regulations, guidelines, and processes governing the FDA, the biomedical industry, other stakeholders, and their interactions. Of particular importance, the FDA Amendments Act of 2007 made public advisory committee meetings mandatory for new molecular entities and devices r...

journal_title：Therapeutic innovation & regulatory science

authors： McIntyre TD,Pappas M,DiBiasi JJ

更新日期：2013-01-01 00:00:00