Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicines.

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：: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：:In general, similar to FDA and other health authorities, the PMDA requires clinical efficacy study(ies) to evaluate equivalence between a reference biological product and a Biosimilar product for new drug applications. Even if an identical clinical efficacy study is included in both of PMDA and FDA submissions, the co...

journal_title：Therapeutic innovation & regulatory science

authors： Asami Y,Pan J,Oh M,Sato A

更新日期：2020-09-01 00:00:00

abstract：:Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effec...

journal_title：Therapeutic innovation & regulatory science

authors： Gould AL,Krishna R,Khan A,Saltzman J

更新日期：2015-03-01 00:00:00

abstract：:In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as adaptive trial designs, real-world data collection, precisi...

journal_title：Therapeutic innovation & regulatory science

authors： Grignolo A,Siu A

更新日期：2019-05-01 00:00:00

abstract：:Lack of adherence to study protocol and missing data are often unavoidable in clinical trials, and both increase the need to differentiate between the ideal treatment effect if the medication is taken as directed and the treatment effect in presence of the actual adherence pattern. In this regard, estimands have becom...

journal_title：Therapeutic innovation & regulatory science

authors： Leuchs AK,Zinserling J,Brandt A,Wirtz D,Benda N

更新日期：2015-07-01 00:00:00

abstract：:Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval a...

journal_title：Therapeutic innovation & regulatory science

authors： Klopfenstein M,Van Campen LE,Garnett T

更新日期：2015-05-01 00:00:00

abstract：:Agents indicated for cleansing of the colon as a preparation for colonoscopy (bowel preps) are among the most frequently prescribed drugs for otherwise healthy patients. Better bowel preparation has been shown to translate into higher adenoma detection rates. Therefore, safety and efficacy standards need to be high. C...

journal_title：Therapeutic innovation & regulatory science

authors： Gottlieb K,Turner JR,Gillespie BS,Hussain F

更新日期：2015-09-01 00:00:00

abstract：BACKGROUND:Several articles showed that statistical efficiency of multi-arm randomized clinical trials (RCTs) is much better than conventional two-arm RCTs. Multi-arm RCTs attract interest mainly when the experimental treatment regimen is not optimized or several pipelines under development exist. Breast cancer is a po...

journal_title：Therapeutic innovation & regulatory science

authors： Nomura S,Miyauchi Y,Ajisawa Y,Isogaya K,Sozu T

更新日期：2020-09-01 00:00:00

abstract：BACKGROUND:The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the pre...

journal_title：Therapeutic innovation & regulatory science

authors： Schultz-Knudsen K,Sabaliauskaite U,Hellsten J,Lassen AB,Morant AV

更新日期：2020-11-23 00:00:00

abstract：BACKGROUND:Access and use of historical control data was identified as a top stakeholder concern across organizations according to results of a survey of needs and challenges related to nonclinical data conducted by the FDA/PhUSE Nonclinical Working Group in 2011. There is a perception there may be additional ways to c...

journal_title：Therapeutic innovation & regulatory science

authors： Mihalcik LM,Bausman M,Brown P,Everds N,Feldmann J,Henck J,Potenta D,Sims J,Zandee J

更新日期：2016-03-01 00:00:00

abstract：BACKGROUND:A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. Few guidance documents are available that address the operations and mechanics of establishing, serving on, or reporting to a DMC. This article provides a practical guide to sponsors, inst...

journal_title：Therapeutic innovation & regulatory science

authors： Bierer BE,Li R,Seltzer J,Sleeper LA,Frank E,Knirsch C,Aldinger CE,Levine RJ,Massaro J,Shah A,Barnes M,Snapinn S,Wittes J

更新日期：2016-09-01 00:00:00

abstract：:The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulat...

journal_title：Therapeutic innovation & regulatory science

authors： Han FV,Weiss K

更新日期：2019-07-01 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：BACKGROUND:Although a large number of clinical trials have been conducted, the types of clinical trials that are scientifically influential, frequently utilized by society, and contribute to the progress of evidence-based medicine (EBM) have not been studied. Thus, we aimed to investigate the relationship between the c...

journal_title：Therapeutic innovation & regulatory science

authors： Noguchi Y,Kaneko M,Narukawa M

更新日期：2020-11-01 00:00:00

abstract：BACKGROUND:A new incentive program, "Premium Rewards for the Promotion of Innovative Drug Discovery and Resolution of Off-Label Use, etc," was introduced in Japan in 2010 and subsequently applied in 2010, 2012, and 2014. In our previous study, we reported statistical evidence regarding the attributes of drugs for which...

journal_title：Therapeutic innovation & regulatory science

authors： Shibata S,Uemura R,Suzuki T

更新日期：2016-01-01 00:00:00

abstract：BACKGROUND:The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds that the speed of innovation is sluggish, pressure for chang...

journal_title：Therapeutic innovation & regulatory science

authors： Robberson M,Breder CD

更新日期：2020-08-31 00:00:00

abstract：BACKGROUND:The coherence between the relationship of QTc and drug plasma concentration (this relationship is measured through the slope) and ICH E14 findings based on hundreds of QT study reports was studied. RESULTS:Based on ICH E14 analysis, our findings indicate that if the slope was not positive, in most cases (86...

journal_title：Therapeutic innovation & regulatory science

authors： Zhang J,Chen H,Tsong Y,Stockbridge N

更新日期：2015-05-01 00:00:00

abstract：:The authors consider a statistically valid method that has little concern caused by down weighting in stage 2 or slight loss in efficiency and possibly improves power performance for a trial design that allows for adaptation of statistical information. In addition to the need for a priori sound data-based planning tha...

journal_title：Therapeutic innovation & regulatory science

authors： Wang SJ,Hung HMJ

更新日期：2014-01-01 00:00:00

abstract：BACKGROUND:Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item asse...

journal_title：Therapeutic innovation & regulatory science

authors： Wehmeier PM,Fox T,Doerr JM,Schnierer N,Bender M,Nater UM

更新日期：2019-07-14 00:00:00

abstract：BACKGROUND:According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) ...

journal_title：Therapeutic innovation & regulatory science

authors： Bai HK,Ahearn JD,Bartlett MG

更新日期：2020-10-23 00:00:00

abstract：:Meta-analyses are increasingly influencing clinical practice, but significant methodological flaws have been reported. The purpose of this study was to evaluate the quality of search strategies utilized by anti-infective meta-analyses. The Embase database was searched for meta-analyses evaluating anti-infective drug t...

journal_title：Therapeutic innovation & regulatory science

authors： Marler JL,Curry KY,Suda KJ

更新日期：2014-05-01 00:00:00

abstract：BACKGROUND:Medical information (MI) departments across pharmaceutical companies respond to medical inquiries about a company's products to healthcare providers, payors, patients, and caregivers. Responses provided are constructed to be relevant, accurate, scientifically balanced and delivered in a timely manner. Benchm...

journal_title：Therapeutic innovation & regulatory science

authors： Byun J,Jong JA,Gangat A,Flowers T,Gazo A,Shah I

更新日期：2020-11-01 00:00:00

abstract：BACKGROUND:(1) To assess the differing viewpoints of actual and potential adult clinical trial participants in 5 age cohorts, (2) identify misperceptions and opportunities to reduce unnecessary burdens on volunteers, and (3) provide age-specific feedback to study sponsors on their current engagement efforts. METHODS:B...

journal_title：Therapeutic innovation & regulatory science

authors： Anderson A,Borfitz D,Getz K

更新日期：2020-01-01 00:00:00

abstract：BACKGROUND:The human papillomavirus (HPV) vaccine coverage is very low in Japan since the government suspended the active encouragement of the vaccination. We aimed to conduct a benefit-risk assessment of HPV vaccination and explore different consequent scenarios to identify potential improvements to the current Japane...

journal_title：Therapeutic innovation & regulatory science

authors： Matsumoto T,Matsumaru N,Scuffham P,Neels P,Tsukamoto K

更新日期：2021-01-01 00:00:00

abstract：:Time progression models provide a significant advantage in developing clinical trials and can also be used to elicit comparisons among therapeutic agents. The authors performed a meta-analysis to construct a time progression model for rheumatoid arthritis (RA), an area of significant interest for pharmaceutical develo...

journal_title：Therapeutic innovation & regulatory science

authors： Reeve R,Pang L,Ferguson B,O'Kelly M,Berry S,Xiao W

更新日期：2013-11-01 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

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：BACKGROUND:Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. METHODS:This paper discusses data sources a...

journal_title：Therapeutic innovation & regulatory science

authors： Izem R,Sanchez-Kam M,Ma H,Zink R,Zhao Y

更新日期：2018-03-01 00:00:00

abstract：:A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, as it would result in the systematic structured approach to support transparency in decision making. Several...

journal_title：Therapeutic innovation & regulatory science

authors： Walker S,McAuslane N,Liberti L,Leong J,Salek S

更新日期：2015-01-01 00:00:00