The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan.

abstract：BACKGROUND:Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 an...

journal_title：Therapeutic innovation & regulatory science

authors： Pampulevski V,Giaquinto JR,Rametta M,Toscani M,Barone J,Nadal JC

更新日期：2020-01-01 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：:Using a measure of agreement that does not distinguish the "positive" outcome from the "negative" outcome can be sometimes misleading in assessing resemblance. To alleviate this concern, some new indices, including the "positive" and "negative" conditional synchrony measures (CSM) (or the conditional discordant measur...

journal_title：Therapeutic innovation & regulatory science

authors： Lui KJ

更新日期：2020-03-01 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：:When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agencies. Thus, misleading advertising is the most difficult problem with the turnover of these products if information in the commercials does not correspond to the informat...

journal_title：Therapeutic innovation & regulatory science

authors： Lozda R

更新日期：2020-01-01 00:00:00

abstract：BACKGROUND:Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA's Benefit-Risk Framework (BRF). This present metho...

journal_title：Therapeutic innovation & regulatory science

authors： Sun S,Heske S,Mercadel M,Wimmer J

更新日期：2021-01-01 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：: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：:Quality and safety tests are required for regulatory approval of drugs and pharmaceuticals in the country to guarantee minimum safety standards, and most of these tests include animal usage. In the case of biological medicines, these safety and quality tests have to be performed on a batch-to-batch basis and require a...

journal_title：Therapeutic innovation & regulatory science

authors： Rastogi S,Kalaivani M,Bhatia AK,Prakash J,Singh GN

更新日期：2015-09-01 00:00:00

abstract：BACKGROUND:The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized that if the structures of the two timeseries are similar and/o...

journal_title：Therapeutic innovation & regulatory science

authors： Daizadeh I

更新日期：2020-09-01 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:Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information. METHODS:All English...

journal_title：Therapeutic innovation & regulatory science

authors： Wolf A,Fuchs J,Schweim HG

更新日期：2016-01-01 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：:TransCelerate BioPharma Inc developed a methodology based on the notion that shifting monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring will increase efficiencies and enhance patient safety and data integrity while maintaining adherence to good cli...

journal_title：Therapeutic innovation & regulatory science

authors： Barnes S,Katta N,Sanford N,Staigers T,Verish T

更新日期：2014-09-01 00:00:00

abstract：BACKGROUND:Uncertain ascertainment of events in clinical trials has been noted for decades. To correct possible bias, Clinical Endpoint Committees (CECs) have been employed as a critical element of trials to ensure consistent and high-quality endpoint evaluation, especially for cardiovascular endpoints. However, the ef...

journal_title：Therapeutic innovation & regulatory science

authors： Chen Y,Lawrence J,Hung HMJ,Stockbridge N

更新日期：2021-01-01 00:00:00

abstract：:After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Althoug...

journal_title：Therapeutic innovation & regulatory science

authors： Schulthess D,Baird LG,Trusheim M,Unger TF,Lumpkin M,Hoos A,Garner S,Gavin P,Goldman M,Seigneuret N,Chlebus M,Van Baelen K,Bergstrom R,Hirsch G

更新日期：2016-05-01 00:00:00

abstract：BACKGROUND:Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investin...

journal_title：Therapeutic innovation & regulatory science

authors： Severin T,Corriol-Rohou S,Bucci-Rechtweg C,An Haack K,Fuerst-Recktenwald S,Lepola P,Norjavaara E,Dehlinger-Kremer M,EFGCP Children’s Medicines Working Party.,Haertter S,Cheung SYA,IQ Pediatric Working Group.

更新日期：2020-09-01 00:00:00

abstract：:A growing number of organizations-including pharmaceutical and biotechnology companies, foundations and associations-are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and pers...

journal_title：Therapeutic innovation & regulatory science

authors： Anderson A,Getz KA

更新日期：2018-07-01 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：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：:In March 2017, the US FDA introduced the new Regenerative Medicine Advanced Therapy (RMAT) designation thus recognizing the enormous potential of these medicines and the need for efficient regulatory tools to accelerate their development and their commercial availability. The development of regenerative medicines is v...

journal_title：Therapeutic innovation & regulatory science

authors： Vaggelas A,Seimetz D

更新日期：2019-05-01 00:00:00

abstract：OBJECTIVE:To identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in SAARC (South Asian Association for Regional Cooperation) nations. METHODS:Studies published in English language between 1990 and 2015 were retrieved from Medline d...

journal_title：Therapeutic innovation & regulatory science

authors： Mehta M,Nerurkar R

更新日期：2018-05-01 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：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：: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: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 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：: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：: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：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...

journal_title：Therapeutic innovation & regulatory science

authors： Shibata S,Fukumoto D,Suzuki T,Ozaki K

更新日期：2019-07-16 00:00:00