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Standardization Consensus of a Hospital Drug Database: An Efficient Tool
Therapeutic innovation & regulatory science, 2020, Vol.54 (1), p.85-92
2020
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An Alternative to Disproportionality: A Frequency-Based Method for Pharmacovigilance Data Mining
Therapeutic innovation & regulatory science, 2018-05, Vol.52 (3), p.294-299
2018
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Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan
Therapeutic innovation & regulatory science, 2018-07, Vol.52 (4), p.442-448
2018
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Entry Into New Therapeutic Areas: The Effect of Alliance on Clinical Trials
Therapeutic innovation & regulatory science, 2019-09, Vol.53 (5), p.648-653
2019
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Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data
Therapeutic innovation & regulatory science, 2023-05, Vol.57 (3), p.570-579
2023
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How Did These Data Get Here? Recommendations for the Analysis of Data From ClinicalTrials.gov
Therapeutic innovation & regulatory science, 2019-09, Vol.53 (5), p.639-640
2019
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Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010-2015: Implications for Designing a Regulatory Shortcut to New Drug Application
Therapeutic innovation & regulatory science, 2017-01, Vol.51 (1), p.111-117
2017
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ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials
Therapeutic innovation & regulatory science, 2015-03, Vol.49 (2), p.218-224
2015
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Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct
Therapeutic innovation & regulatory science, 2016-03, Vol.50 (2), p.144-154
2016
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Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan
Therapeutic innovation & regulatory science, 2021-05, Vol.55 (3), p.539-544
2021
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Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database
Therapeutic innovation & regulatory science, 2011-07, Vol.45 (4), p.421-430
2011
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Postmarketing Benefit-Risk Assessment for Erythropoiesis-Stimulating Agents Using a Health Care Database
Therapeutic innovation & regulatory science, 2016-11, Vol.50 (6), p.823-832
2016
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Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression
Therapeutic innovation & regulatory science, 2016-11, Vol.50 (6), p.743-750
2016
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Factors Related to Regulatory Approval of Late-Stage Development Compounds: Analysis of Japanese Pharmaceutical Company Activities, 1995-2007
Therapeutic Innovation & Regulatory Science, 2013-03, Vol.47 (2), p.261-267
2013
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Assessment of Pharmaceutical Research and Development Productivity with a Novel Net Present Value-based Project Database
Therapeutic innovation & regulatory science, 2011-03, Vol.45 (2), p.175-185
2011
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A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan
Therapeutic innovation & regulatory science, 2015-09, Vol.49 (5), p.720-729
2015
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An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees
Therapeutic innovation & regulatory science, 2015-09, Vol.49 (5), p.698-705
2015
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Safety Information From Spontaneous and Literature Adverse Reaction Reports: A Comparison
Therapeutic Innovation & Regulatory Science, 2013-03, Vol.47 (2), p.248-255
2013
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Describing the Endpoint: Consistency Across Protocols, Study Reports, Postings, and Publications
Therapeutic innovation & regulatory science, 2017-05, Vol.51 (3), p.304-306
2017
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Evaluation of Drug Adverse Event Intake and Reporting in a Medical Information Service
Therapeutic Innovation & Regulatory Science, 2011-11, Vol.45 (6), p.767-773
2011
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Regulatory Informatics Reveals Minimal Residual Disease Trends in Hematologic Malignancies
Therapeutic innovation & regulatory science, 2016-05, Vol.50 (3), p.319-329
2016
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Investigation of the Safety Profiles of Japanese Clinical Trials
Therapeutic innovation & regulatory science, 2014-05, Vol.48 (3), p.308-315
2014
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Investigation of Characteristics of Japanese Clinical Trials in Terms of Data Variability
Therapeutic Innovation & Regulatory Science, 2013-07, Vol.47 (4), p.430-437
2013
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Responsible Parties—Is It Time to Clean Up Your ACTs?
Therapeutic innovation & regulatory science, 2014-09, Vol.48 (5), p.651-657
2014
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Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database
Therapeutic innovation & regulatory science, 2018-05, Vol.52 (3), p.339-347
2018
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