Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations.

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：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：:In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regul...

journal_title：Therapeutic innovation & regulatory science

authors： O'Brien J,Lumsden RS,Diehl DH,Macdonald JC

更新日期：2020-03-01 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：: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：: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：: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:Substance abuse research can raise ethical concerns about the comprehension and decision-making capacities of participants with drug dependence. In this study, the competence and willingness to consent to research participation were examined among patients with heroin dependence. METHODS:Twenty patients wit...

journal_title：Therapeutic innovation & regulatory science

authors： Zhao L,Shi H,Ying B,Li Q

更新日期：2020-09-01 00:00:00

abstract：:Risk-based monitoring (RBM) has disrupted the clinical trial industry, challenging conventional monitoring norms, business processes, and organizational structures. Endorsed by regulators and leading industry forums, and further driven by escalating drug development costs and enabling technology shifts making data ava...

journal_title：Therapeutic innovation & regulatory science

authors： Limaye N,Jaguste V

更新日期：2019-03-01 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：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：: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 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: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：: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：: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

authors： Seltzer JH,Li J,Wang W

更新日期：2019-03-29 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:Increasing generic drug price competition by facilitating abbreviated new drug applications (ANDA) submission may help patients have access to affordable care. This study examined factors associated with first ANDA submission for the brand drug to be copied [the "reference listed drug" (RLD)]. METHODS:This ...

journal_title：Therapeutic innovation & regulatory science

authors： Wittayanukorn S,Rosenberg M,Schick A,Hu M,Wang Z,Babiskin A,Lionberger R,Zhao L

更新日期：2020-11-01 00:00:00

abstract：:Although much information is already available publically from information-sharing initiatives such as ClinicalTrials.gov, information about clinical programs is unstructured, inconsistent, and incomplete. Clinical research within bioscience companies, health care, academia, and governmental agencies could benefit fro...

journal_title：Therapeutic innovation & regulatory science

authors： Vasko L,Sundgren M,Bachmann P,Balinski K,Bleich N,Blom T,Eriksson H,Ferendo R,Forsberg K,King D,Mordiva A,Proeve J,Thomas L,Witch E,Simán M

更新日期：2015-01-01 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

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

authors： Gregg A,Getz N,Benger J,Anderson A

更新日期：2019-05-22 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: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：: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：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

authors： Stergiopoulos S,Eustace C,Stem K,Getz KA

更新日期：2016-07-01 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: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：: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: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：: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