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Therapeutic Innovation & Regulatory Science

ISSN Print: 2168-4790

ISSN Online: 2168-4804

主页: https://journals.sagepub.com/loi/dijc

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Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information

Aarti S. Patel,Allison Soloff,Andrew Ga？o,Anna Markel Vaysman,Carolle A. Stevens,Daniel Boulos,Dominick Albano,Ina Shah,Jane Oreper,Michael S. Rocco,Pooja Gandhi,Richa Shah,Suzana A. Giffin,Teresa Flowers,Thomas Malieckal

Baseline Assessment of the Evolving 2017 eClinical Landscape

Beth Harper,Brittany Machion,Ken Getz,Michael Wilkinson,Richard Young

Building Trust in RWE Will Support Clearer Regulatory Uses

Gregory Daniel

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

Daichi Mori,Katsura Tsukamoto,Kazuhiko Chikazawa,Masako Doi,Miriam Cnop,Naoki Matsumaru,Shoen Kume,Takayuki Anazawa

A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC)

Alison Bateman-House,Arthur Caplan,Joanne Waldstreicher,Jon Ukropec,Lisa Fedor,Ramana Sonty,Rick Jansson,Tito Roccia

Possible Causes of Failing to Meet Primary Endpoints: A Systematic Review of Randomized Controlled Phase 3 Clinical Trials in Patients With Non–Small Cell Lung Cancer

Masahiro Tohkin,Mitsugu Ikeda,Tatsuya Ochibe

Statistical Practices of Safety Monitoring: An Industry Survey

Faiz Ahmad,Greg Ball,Michael W. Colopy,Robert Gordon,Susan P. Duke,William W. Wang

Expediting Drug Development: FDA’s New Regenerative Medicine Advanced Therapy Designation

Annegret Vaggelas,Diane Seimetz

Youth Experience With Community Pharmacy Services and Their Perceptions Toward Implementation of Medication Therapy Management Services by Community Pharmacists in the Western Region of Saudi Arabia

Mahmoud S. Alhaddad

Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development

Allan Chow,Beata Rygiel-Zbikowska,Irene Tomlin,Jonathan Rowe,Kevin Joseph Wilson,Marion Pillwein,Martin Ryan,Melissa Suprin

Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development

Beata Rygiel-Zbikowska,Diane Puglia Ryan,Griet Vangheel,Lora Lee Zoller-Neuner,Michael Edward Husovich,Odette Anyangwe,Ruzica Zadro

Influence of Drug Lag on New Drug Label Revisions

Chikara Kikuchi,Hitoshi Shimomura,Miyako Murakami,Shuji Shimada,Takao Aoyama

Comparison of Brief Summary Formats Through a Health Literacy Lens

Anthony Eleftherion,Katherine Simpson,Linda Neuhauser,Lori Hall,Michele L. Sharp

Reported Adverse Drug Reactions During the Use of Corticosteroids in a Tertiary Care Hospital

Sarika Paradkar

Regulatory Trends in Drug Development in Asia Pacific

Fengyun (Vicky) Han,Karen Weiss

The Use of Microblog “Weibo” by Chinese Patent Medicine Companies in China

Carolina Oi Lam Ung,Daisheng Tang,Hao Hu,Qirui Song

A Transitional Probability Model for Parkinson’s Disease Motor States With Applications to Missing Data

Phillip Dinh

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G. Strauss,Gary Gintant,J. Rick Turner,Jose Vicente,Ksenia Blinova,Philip T. Sager,Wendy Wu,Zhihua Li

Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China

Carolina Oi Lam Ung,Linfeng Hu,Qingwen Yuan,Yuanjia Hu,Zhong Yu

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

Katsura Tsukamoto,Makoto Tanaka,Naoki Matsumaru

Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols

Bouchra Benettaib,Gilles Vassal,Gregory Reaman,Kenneth Cohen,Mark Fleury,Mark Stewart,Martha Donoghue,Nita Seibel,Raleigh Malik,Rapha？l Rousseau,Samuel Blackman,Tahira Khan

Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Gang Wang,Jianhong Pan,Jinbo Yang,Jingjing Han,Jun Wang,Min Li,Xin Zeng

Perceived Burden of Completion of Patient

Bill Byrom,Emuella Flood,Mabel Crescioni,Serge Bodart,Sonya Eremenco

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Carol Y. Kim,Daiva Shetty,Eunjung Esther Chuh,Johnny Young,Julia Lee,Lewis J. Fermaglich,Ru Chen,Teena Thomas,Ying Fan

Evaluating the Completeness of ClinicalTrials.gov

Christine Blazynski,Kenneth A. Getz,Stella Stergiopoulos

A Vision for Therapeutic Innovation & Regulatory Science

Gregory Daniel

Risk

Nimita Limaye,Veena Jaguste

Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient

Celeste A. Elash,Cindy Howry,Mabel Crescioni,Paul O’Donohoe,Sonya Eremenco,Tracey Rothrock

Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective

Kaori Kido,Katsura Tsukamoto,Naoki Matsumaru

Use of Proprietary Names by Prescribers When Prescribing Over

Chi-Ming Tu

Technology Forecasting for Medical Devices Guidance Formulation: A Case Study in Japan

Sayaka Itoh,Shingo Kano

Measurement Equivalence of Patient

Ari Gnanasakthy,Ashley Slagle,Bill Byrom,Chad Gwaltney,Willie Muehlhausen

Unique Burdens of Pediatric Clinical Trials in Duchenne Muscular Dystrophy, April 20

Kathi Kinnett,Timothy Franson,Timothy P. Cripe

Unresectable and Metastatic Melanoma of the Skin: Literature Review of Clinical Trials and Efficacy Endpoints Since 2000

Pallavi S. Mishra-Kalyani,Rajeshwari Sridhara,Susan Jin

Comparison of Postdoctoral Pharmacy Training Programs: Drug Information Residencies and Medical Information Fellowships

Evelyn R. Hermes-DeSantis,Jimmy Gonzalez,Lesley Fierro,Michael Hogan,Samantha Bryant,Sandra Bai

Benefits and Risks of Nonsteroidal Anti

Charles H. Hennekens,Jennifer G. Foster,Manas A. Rane,Patricia R. Hebert,Sarah K. Wood

Managing the Risks of Medicines: An Examination of FDA’s Application of Criteria for Requiring a REMS

Katie Stabi,Paul J. Seligman,Rebekah H. Anguiano,Thomas Felix

An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

Brian Edwards,Philip T. Lance,Ruth V. Greenaway

An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

Issis Kelly-Pumarol,Joseph E. Andrews

Comparison of Sample Size by Bootstrap and by Formulas Based on Normal Distribution Assumption

Zuozhen Wang

Practical Issues in Clinical Inspection Process

Fuyu Song,Jianming Li,Minghuang Hong,Shein-Chung Chow,Xue Qian

Evidence

Brian Wood,Emily Hawryluk,Jeffrey Niemira,John J. Doyle

US Medical Information Websites Benchmarking: How Is the Industry Fairing in Usability?

Etienne Paquette-Lemieux,Rania Gaspo,Steven Hays

How 4 Companies Became One: Co

Gregory Golm,James Mancuso,Sajda Ghani,Susan Huyck,Tarra Irvin

Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

Kavosh Zandsalimi,Lobat Tayebi,Reza Masaeli

The Role of Worst

J. Rick Turner

Special Considerations for Proprietary Name Review: Focus on Products That May Be Prescribed “As Directed”

Briana B. Rider,Hina Mehta,Lubna Merchant

Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program

Anjelica Davis,Gissoo DeCotiis,Ian Banks,Lisa Schlager,Ryan Hohman,Wendy Selig

Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines

David K. Raynor,Hsiu-Chun Tony Yuan,Parisa Aslani

How Does “Regulatory Practice” Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan

Il Young Cho,Ki Hwan Choi,Yhun Yhong Sheen

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