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 Reporting System database of the FDA. EM was considered a mild reaction, and SJS and TEN were considered severe reactions. In this study, a new concept termed the "risk of aggravation" (ROA) was defined as whether a certain drug is more likely to cause severe adverse reactions than mild ones. Partial least squares and logistic regression analysis were applied using binary response variable ROAs. These analyses correctly predicted 50 of the 72 drugs associated with SJS and/or TEN and 28 of the 38 drugs associated with EM using binary chemical descriptors that are the same as those using the metric chemical descriptors.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Shirakuni Y,Okamoto K,Uejima E,Inui S,Takahara JI,Ohgaru T,Yamasaki H,Tian Y,Kawashita N,Inoue R,Yasunaga T,Takagi Tdoi
10.1177/0092861512460759subject
Has Abstractpub_date
2013-03-01 00:00:00pages
235-241issue
2eissn
2168-4790issn
2168-4804journal_volume
47pub_type
杂志文章abstract:BACKGROUND:Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of ...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479017716490
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abstract:BACKGROUND:In the breakthrough therapy designation (BTD) and Sakigake designation programs, rolling submission and close communication between applicants and regulatory authorities enable the timely access of patients to innovative medicines. However, challenges in the quality development, including chemistry, manufact...
journal_title:Therapeutic innovation & regulatory science
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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
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doi:10.1177/2168479015600205
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abstract:BACKGROUND:With the pharmaceutical industry's increased attention on enhancing patient experiences during their participation in clinical trials, the use of mobile nurse (MN) services to support the conduct of clinical trial assessments in the home (or in alternative locations other than in investigational sites) has b...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479015625712
更新日期:2016-07-01 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
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doi:10.1177/2168479012467018
更新日期:2013-03-01 00:00:00
abstract::The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity con...
journal_title:Therapeutic innovation & regulatory science
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abstract::Large electronic health care databases can be used to evaluate the effectiveness of regulatory action. Designing and interpreting such studies can be challenging. We demonstrate using case studies on modafinil, benzodiazepines, dosulepin, and piroxicam that measuring the impact of regulatory action is possible and can...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479015570333
更新日期:2015-07-01 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
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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
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doi:10.1177/2168479014522468
更新日期:2014-07-01 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
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更新日期:2016-03-01 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
pub_type: 杂志文章,评审
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更新日期:2018-03-01 00:00:00
abstract::Attention deficit hyperactivity disorder (ADHD) is the most common neurobiological disorder in children, with a prevalence of ~6-7%1,2 that has remained stable for decades2. The social and economic burden associated with patients3, families, and broader systems (healthcare/educational) is substantial, with the annual ...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479015599811
更新日期:2015-09-01 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
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doi:10.1177/2168479014546336
更新日期:2014-09-01 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
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doi:10.1177/2168479014563549
更新日期:2015-05-01 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
pub_type: 杂志文章
doi:10.1007/s43441-020-00177-5
更新日期:2020-11-01 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
pub_type: 杂志文章
doi:10.1007/s43441-020-00206-3
更新日期:2021-01-01 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
pub_type: 杂志文章
doi:10.1007/s43441-020-00161-z
更新日期:2020-11-01 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
pub_type: 杂志文章
doi:10.1177/2168479019849879
更新日期:2019-07-14 00:00:00
abstract:BACKGROUND:(1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and admin...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479019849875
更新日期:2019-05-22 00:00:00
abstract::The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological condition...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
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更新日期:2020-05-01 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
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更新日期:2019-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2019-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018769284
更新日期:2019-03-01 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
pub_type: 杂志文章
doi:10.1177/2168479015580382
更新日期:2015-11-01 00:00:00
abstract::The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section. ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018793130
更新日期:2019-03-29 00:00:00
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
pub_type: 杂志文章
doi:10.1177/2168479018769292
更新日期:2019-01-01 00:00:00
abstract::Biopharmaceutical medicines are complex molecules obtained from a living organism (plant or animal cells) and may contain components of a living organism using biotechnology. Biosimilars are closely similar to already approved biopharmaceutical products that could form a new generation of medicines that are available ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-020-00112-8
更新日期:2020-09-01 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
pub_type: 杂志文章
doi:10.1007/s43441-020-00228-x
更新日期:2020-10-23 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
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更新日期:2020-09-01 00:00:00