Found: 57
Select item for more details and to access through your institution.
Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Factors affecting the association between overall survival and progression-free survival in clinical trials of first-line treatment for patients with advanced non-small cell lung cancer.
- Published in:
- Journal of Cancer Research & Clinical Oncology, 2014, v. 140, n. 5, p. 839, doi. 10.1007/s00432-014-1617-3
- By:
- Publication type:
- Article
Investigation of the relationship between a starting dose in first-in-human studies and no observed adverse effect level in nonclinical studies.
- Published in:
- International Journal of Clinical Pharmacology & Therapeutics, 2014, v. 52, n. 9, p. 770, doi. 10.5414/CP202116
- By:
- Publication type:
- Article
Comparison of safety outcomes of anticancer drugs in Japanese and non-Japanese patients in multi-regional clinical trials: meta-analysis of safety profiles.
- Published in:
- Investigational New Drugs, 2023, v. 41, n. 3, p. 483, doi. 10.1007/s10637-023-01362-7
- By:
- Publication type:
- Article
Oncology drug lag in Japan: has it improved over the last decade?
- Published in:
- International Journal of Clinical Oncology, 2023, v. 28, n. 11, p. 1451, doi. 10.1007/s10147-023-02395-x
- By:
- Publication type:
- Article
Comparison of efficacy outcomes of anticancer drugs between Japanese patients and the overall population.
- Published in:
- International Journal of Clinical Oncology, 2021, v. 26, n. 2, p. 296, doi. 10.1007/s10147-020-01804-9
- By:
- Publication type:
- Article
Magnitude of advantage in tumor response contributes to a better correlation between treatment effects on overall survival and progression-free survival: a literature-based meta-analysis of clinical trials in patients with metastatic colorectal cancer.
- Published in:
- International Journal of Clinical Oncology, 2020, v. 25, n. 5, p. 851, doi. 10.1007/s10147-020-01619-8
- By:
- Publication type:
- Article
Assessment of Cardiovascular Risk With Glucagon-Like Peptide 1 Receptor Agonists in Patients With Type 2 Diabetes Using an Alternative Measure to the Hazard Ratio.
- Published in:
- 2018
- By:
- Publication type:
- journal article
Assessment of the Risk of Hospitalization for Heart Failure With Dipeptidyl Peptidase-4 Inhibitors, Saxagliptin, Alogliptin, and Sitagliptin in Patients With Type 2 Diabetes, Using an Alternative Measure to the Hazard Ratio.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Acceptability of Manufacturer-Proposed Utility Values for NICE Cancer Medicine Appraisals: Analysis of Manufacturers' Information Sources.
- Published in:
- International Journal of Technology Assessment in Health Care, 2022, v. 38, n. 1, p. 1, doi. 10.1017/S0266462322000149
- By:
- Publication type:
- Article
Medicine characteristics affecting the time to guidance publication by National Institute for Health and Care Excellence in the single technology appraisal process.
- Published in:
- International Journal of Technology Assessment in Health Care, 2022, v. 38, n. 1, p. 1, doi. 10.1017/S0266462321001677
- By:
- Publication type:
- Article
Acceptability of Manufacturer-Proposed Utility Values for NICE Cancer Medicine Appraisals: Analysis of Manufacturers' Information Sources.
- Published in:
- International Journal of Technology Assessment in Health Care, 2021, v. 38, n. 1, p. 1, doi. 10.1017/S0266462322000149
- By:
- Publication type:
- Article
Medicine characteristics affecting the time to guidance publication by National Institute for Health and Care Excellence in the single technology appraisal process.
- Published in:
- International Journal of Technology Assessment in Health Care, 2021, v. 38, n. 1, p. 1, doi. 10.1017/S0266462321001677
- By:
- Publication type:
- Article
Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.
- Published in:
- British Journal of Clinical Pharmacology, 2019, v. 85, n. 6, p. 1270, doi. 10.1111/bcp.13893
- By:
- Publication type:
- Article
Factors Affecting Efficacy and Safety of Add-On Combination Chemotherapy for Non-Small-Cell Lung Cancer: A Literature-Based Pooled Analysis of Randomized Controlled Trials.
- Published in:
- Lung, 2012, v. 190, n. 4, p. 355, doi. 10.1007/s00408-012-9379-7
- By:
- Publication type:
- Article
Randomized controlled trial data for successful new drug application for rare diseases in the United States.
- Published in:
- Orphanet Journal of Rare Diseases, 2023, v. 18, n. 1, p. 1, doi. 10.1186/s13023-023-02702-9
- By:
- Publication type:
- Article
Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis.
- Published in:
- International Urology & Nephrology, 2018, v. 50, n. 6, p. 1021, doi. 10.1007/s11255-018-1869-y
- By:
- Publication type:
- Article
Decision and timing of safety‐related labeling changes for new drugs in Japan: Comparison with the United States and the European Union.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2023, v. 32, n. 12, p. 1331, doi. 10.1002/pds.5664
- By:
- Publication type:
- Article
A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2021, v. 30, n. 5, p. 561, doi. 10.1002/pds.5203
- By:
- Publication type:
- Article
Increased availability of drugs is correlated with the number of patients diagnosed thereafter: Data analysis of 45 intractable diseases.
- Published in:
- Journal of Clinical Pharmacy & Therapeutics, 2021, v. 46, n. 5, p. 1319, doi. 10.1111/jcpt.13434
- By:
- Publication type:
- Article
Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study.
- Published in:
- Journal of Clinical Pharmacy & Therapeutics, 2020, v. 45, n. 3, p. 496, doi. 10.1111/jcpt.13096
- By:
- Publication type:
- Article
Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer.
- Published in:
- European Journal of Clinical Pharmacology, 2019, v. 75, n. 9, p. 1193, doi. 10.1007/s00228-019-02695-0
- By:
- Publication type:
- Article
Influence of Prevalent Vertebral Fracture on the Correlation between Change in Lumbar Spine Bone Mineral Density and Risk of New Vertebral Fracture: A Meta-Analysis of Randomized Clinical Trials.
- Published in:
- Clinical Drug Investigation, 2020, v. 40, n. 1, p. 15, doi. 10.1007/s40261-019-00868-4
- By:
- Publication type:
- Article
Meta-analysis of Dropout Rates in Placebo-Controlled Randomized Clinical Trials of Atypical Antipsychotics Assessed by PANSS.
- Published in:
- Clinical Drug Investigation, 2019, v. 39, n. 10, p. 917, doi. 10.1007/s40261-019-00813-5
- By:
- Publication type:
- Article
Time-Matched Evaluation of Cardiovascular Risks Associated with Drugs for Type 2 Diabetes Mellitus.
- Published in:
- Clinical Drug Investigation, 2019, v. 39, n. 5, p. 469, doi. 10.1007/s40261-019-00770-z
- By:
- Publication type:
- Article
Effects of Sodium-glucose Cotransporter 2 Inhibitors on Amputation, Bone Fracture, and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus Using an Alternative Measure to the Hazard Ratio.
- Published in:
- Clinical Drug Investigation, 2019, v. 39, n. 2, p. 179, doi. 10.1007/s40261-018-0731-4
- By:
- Publication type:
- Article
Correction to: Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.
- Published in:
- 2018
- By:
- Publication type:
- Correction Notice
Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.
- Published in:
- Clinical Drug Investigation, 2018, v. 38, n. 8, p. 751, doi. 10.1007/s40261-018-0661-1
- By:
- Publication type:
- Article
Factors Related to the Glucose-Lowering Efficacy of Dipeptidyl Peptidase-4 Inhibitors: A Systematic Review and Meta-Analysis Focusing on Ethnicity and Study Regions.
- Published in:
- Clinical Drug Investigation, 2017, v. 37, n. 3, p. 219, doi. 10.1007/s40261-016-0478-8
- By:
- Publication type:
- Article
An Investigation of Factors Contributing to Higher Levels of Placebo Response in Clinical Trials in Neuropathic Pain: A Systematic Review and Meta-Analysis.
- Published in:
- Clinical Drug Investigation, 2015, v. 35, n. 2, p. 67, doi. 10.1007/s40261-014-0259-1
- By:
- Publication type:
- Article
Investigation of Influencing Factors on Higher Placebo Response in East Asian Versus Western Clinical Trials for Partial Epilepsy: A Meta-Analysis.
- Published in:
- Clinical Drug Investigation, 2013, v. 33, n. 5, p. 315, doi. 10.1007/s40261-013-0077-x
- By:
- Publication type:
- Article
Response to "Have We Found the Key to Unravel Treatment Development Lags for Rare Cancers?: MASTER KEY Project".
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 3, p. 493, doi. 10.1002/cpt.1448
- By:
- Publication type:
- Article
A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 1, p. 153, doi. 10.1002/cpt.1136
- By:
- Publication type:
- Article
Comparison of the Incidence of Adverse Events Between Japanese and Non-Japanese Healthy Subjects in Phase I Studies: A Systematic Review and Meta-Analysis.
- Published in:
- Clinical Drug Investigation, 2024, v. 44, n. 1, p. 11, doi. 10.1007/s40261-023-01327-x
- By:
- Publication type:
- Article
Factors Related to Placebo Response in Randomized, Double-Blind Clinical Trials of Antidepressants in Children and Adolescents: A Meta-regression Analysis.
- Published in:
- Clinical Drug Investigation, 2023, v. 43, n. 6, p. 383, doi. 10.1007/s40261-023-01273-8
- By:
- Publication type:
- Article
Differences Between Japan and the United States in Dosages of Drugs Recently Approved in Japan.
- Published in:
- Journal of Clinical Pharmacology, 2011, v. 51, n. 4, p. 549, doi. 10.1177/0091270010375958
- By:
- Publication type:
- Article
Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 12, p. 1402, doi. 10.1002/pds.4672
- By:
- Publication type:
- Article
Analysis of factors related to the occurrence of important drug‐specific postmarketing safety‐related regulatory actions: A cohort study focused on first‐in‐class drugs.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 12, p. 1393, doi. 10.1002/pds.4634
- By:
- Publication type:
- Article
A note on post-marketing safety study design to characterise time-dependent adverse events.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2007, v. 16, n. 10, p. 1146, doi. 10.1002/pds.1472
- By:
- Publication type:
- Article
Combinations of Drug Candidate Properties Affecting Development Success and Discontinuation for 5 Diseases: Lymphoma, Non–Small Cell Lung Cancer, Arthritis, Depression, and Alzheimer Disease.
- Published in:
- Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1247, doi. 10.1002/jcph.2063
- By:
- Publication type:
- Article
Approval success rates of drug candidates based on target, action, modality, application, and their combinations.
- Published in:
- CTS: Clinical & Translational Science, 2021, v. 14, n. 3, p. 1113, doi. 10.1111/cts.12980
- By:
- Publication type:
- Article
Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial.
- Published in:
- 2022
- By:
- Publication type:
- journal article
Impact of the Economic Status of the Patient's Country of Residence on the Outcome of Oncology Clinical Trials.
- Published in:
- Oncologist, 2022, v. 27, n. 3, p. e244, doi. 10.1093/oncolo/oyab060
- By:
- Publication type:
- Article
Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon.
- Published in:
- PLoS ONE, 2019, v. 14, n. 6, p. 1, doi. 10.1371/journal.pone.0218534
- By:
- Publication type:
- Article
Anti-Tumor Efficacy of Anti-PD-1/PD-L1 Antibodies in Combination With Other Anticancer Drugs in Solid Tumors: A Systematic Review and Meta-Analysis.
- Published in:
- Cancer Control: Journal of the Moffitt Cancer Center, 2022, v. 29, p. 1, doi. 10.1177/10732748221140694
- By:
- Publication type:
- Article
Current state of therapeutic development for rare cancers in Japan, and proposals for improvement.
- Published in:
- Cancer Science, 2018, v. 109, n. 5, p. 1731, doi. 10.1111/cas.13568
- By:
- Publication type:
- Article
Potential Primary Endpoint for Exploratory Clinical Trial in Patients with Overactive Bladder: A Systematic Literature Review.
- Published in:
- LUTS, 2018, v. 10, n. 1, p. 64, doi. 10.1111/luts.12141
- By:
- Publication type:
- Article
Key Characteristics of Database Studies on Drug Effectiveness in the Postmarketing Stage: A Systematic Review.
- Published in:
- Pharmaceutical Medicine, 2021, v. 35, n. 6, p. 327, doi. 10.1007/s40290-021-00406-8
- By:
- Publication type:
- Article
Impact of Advantage in Tumor Response on the Correlation Between Progression-Free Survival and Overall Survival: Meta-Analysis of Clinical Trials in Patients with Advanced Non-Small Cell Lung Cancer.
- Published in:
- Pharmaceutical Medicine, 2021, v. 35, n. 2, p. 81, doi. 10.1007/s40290-021-00383-y
- By:
- Publication type:
- Article
Evaluation of the Implementation of Additional Risk Minimization Activities in Europe, the USA, and Japan.
- Published in:
- Pharmaceutical Medicine, 2019, v. 33, n. 5, p. 417, doi. 10.1007/s40290-019-00303-1
- By:
- Publication type:
- Article