Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia.

abstract：:The volume and diversity of data collected to support each clinical study has increased dramatically in response to the rising scope and complexity of global drug development programs. The Tufts Center for the Study of Drug Development conducted an online survey of 257 unique global companies-77% drug development spon...

journal_title：Therapeutic innovation & regulatory science

authors： Wilkinson M,Young R,Harper B,Machion B,Getz K

更新日期：2019-01-01 00:00:00

abstract：BACKGROUND:Prescription drug labeling is an authoritative source of information that guides the safe and effective use of approved medications. In many instances, however, labeling may fail to be updated as new information about drug efficacy emerges in the postmarket setting. When labeling becomes outdated, it loses i...

journal_title：Therapeutic innovation & regulatory science

authors： Shea MB,Stewart M,Van Dyke H,Ostermann L,Allen J,Sigal E

更新日期：2018-11-01 00:00:00

abstract：BACKGROUND:Contending with a continuously expanding volume and variety of clinical data poses challenges and opportunities for the industry and clinical data management organizations. METHODS:Tufts CSDD conducted an online survey aimed at further quantifying and understanding the magnitude and impact that expanded dat...

journal_title：Therapeutic innovation & regulatory science

authors： Harper B,Wilkinson M,Indupuri R,Rocchio S,Getz K

更新日期：2020-09-14 00:00:00

abstract：BACKGROUND:Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and academic experts in stated-preference research can effectiv...

journal_title：Therapeutic innovation & regulatory science

authors： Wolka AM,Fairchild AO,Reed SD,Anglin G,Johnson FR,Siegel M,Noel R

更新日期：2018-07-01 00:00:00

abstract：:In 2010 Congress established a regulatory pathway for the approval of biosimilar products in the United States. FDA has embarked on developing the implementation framework for this pathway which includes creating guidance to assist biosimilar manufacturers in the development of these products. However, to date, the gu...

journal_title：Therapeutic innovation & regulatory science

authors： Davis GC,Bowker GM

更新日期：2014-05-01 00:00:00

abstract：BACKGROUND:Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpr...

journal_title：Therapeutic innovation & regulatory science

authors： Krumholz-Bahner S,Garibbo M,Getz KA,Widler BE

更新日期：2015-11-01 00:00:00

abstract：:The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options. We compare the systems of both countries and discuss some ethical concerns surrounding non-trial access to investigational drugs. Notable points of comparison of the two countries' systems include cost of non...

journal_title：Therapeutic innovation & regulatory science

authors： Nakada H,Folkers KM,Takashima K

更新日期：2020-10-23 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：BACKGROUND:Communicating the clinical impact of immunogenicity in labeling is important for safe and effective use of certain prescription products. Current U.S. Food and Drug Administration (FDA) guidance does not provide comprehensive recommendations on the communication of clinical impact of immunogenicity in labeli...

journal_title：Therapeutic innovation & regulatory science

authors： Guinn D,Madabushi R,Wang YM,Brodsky E,Zineh I,Maxfield K

更新日期：2020-11-01 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

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：BACKGROUND:The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union. METHODS:Information about approved ant...

journal_title：Therapeutic innovation & regulatory science

authors： Tsukamoto K,Cnop M,Mori D,Kume S,Anazawa T,Doi M,Chikazawa K,Matsumaru N

更新日期：2019-07-01 00:00:00

abstract：BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducte...

journal_title：Therapeutic innovation & regulatory science

authors： Dörr P,Wadworth A,Wang T,McAuslane N,Liberti L

更新日期：2016-11-01 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：:The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of co...

journal_title：Therapeutic innovation & regulatory science

authors： Lunawat S,Bhat K

更新日期：2020-09-01 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：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：:Adaptive designs are increasingly used in clinical trials. The Drug Information Association's Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among regulatory agencies, academia, and pharmaceutical and biotech companies to further the science of adaptive clinical development. The ADSWG S...

journal_title：Therapeutic innovation & regulatory science

authors： Morgan CC,Huyck S,Jenkins M,Chen L,Bedding A,Coffey CS,Gaydos B,Wathen JK

更新日期：2014-07-01 00:00:00

abstract：:The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require drug sponsors to submit a risk evaluation and mitigation strategies (REMS) program for those medicines with serious risks such that failure to effectively manage these risks would tip the benefit-risk balance. As of August 8,...

journal_title：Therapeutic innovation & regulatory science

authors： Cronin M,Berger S,Seligman PJ

更新日期：2014-11-01 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：: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：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：:Japan's rapidly aging population has prompted a change in the country's pharmaceutical care framework from a drug-oriented to a patient-oriented approach. Pharmacies and pharmacists are expected to play central roles in this new patient-oriented approach by reconciling medication and managing polypharmacy, conducting ...

journal_title：Therapeutic innovation & regulatory science

authors： Takamura K,Tachibana K,Kihira T,Nakai K,Tsutsumi Y,Kondoh M

更新日期：2020-09-11 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:The design and sample size of a phase III study for new medical technologies were historically determined within the framework of frequentist hypothesis testing. Recently, drug development using predictive biomarkers, which can predict efficacy based on the status of biomarkers, has attracted attention, and ...

journal_title：Therapeutic innovation & regulatory science

authors： Takazawa A,Morita S

更新日期：2020-09-01 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:Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems. The aims of this study were to evaluate the timelines of the milestones of the South African review process...

journal_title：Therapeutic innovation & regulatory science

authors： Keyter A,Salek S,Gouws J,Banoo S,Walker S

更新日期：2020-07-01 00:00:00

abstract：BACKGROUND:The US Food and Drug Administration (FDA) put out a call for comments on new draft guidance for industry "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA." This call for comments elicited 7 submissions from various organization...

journal_title：Therapeutic innovation & regulatory science

authors： Lance PT,Greenaway RV,Edwards B

更新日期：2019-03-01 00:00:00

abstract：:Probability of success in phase II dominates the drug development cost calculus, with phase I/II as the critical juncture for proof of concept. Failure to address fundamental pharmacologic questions in early development is alarmingly frequent and a strong predictor of failure. Safety, manufacture, formulation, and com...

journal_title：Therapeutic innovation & regulatory science

authors： Cohen O,Sax F

更新日期：2014-09-01 00:00:00

abstract：:Data quality is critical for clinical trials to obtain robust conclusions about drug safety and efficacy evaluation. Effective data quality evaluation has been one of the major obstacles to new drug approvals in China, which hinders innovation in drug discovery and development ultimately. To improve the data quality s...

journal_title：Therapeutic innovation & regulatory science

authors： Wang J,Wang G,Li M,Han J,Zeng X,Pan J,Yang J

更新日期：2019-03-01 00:00:00