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Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology
Clinical trials have become larger and more complex. Thus, eSource should be used to enhance efficiency. This study aimed ...
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
Diabetes, a chronic disease worldwide, may be associated with a poorer prognosis in patients with coronavirus disease 2019...
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results
The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety ...
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry
Medical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but ...
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites
Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical suppl...
Performance Evaluation of Interim Analysis in Bioequivalence Studies
Performance Evaluation of Interim Analysis in Bioequivalence Studies
Under current bioequivalence guidelines in Japan, it is mandatory to establish bioequivalence using a single pivotal study...
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) is a major health problem. It is one of the most common types of stroke and results in mort...
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
The ICH E17 guidelines (2014–2017) on Multiregional Clinical Trials (MRCT) was a joint effort by the regulators and ...
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials
Risk-based quality management is a regulatory-recommended approach to manage risk in a clinical trial. A key element of th...
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective
Chimeric antigen receptor (CAR) T-cell therapy is a human gene therapy product where T cells from a patient are geneticall...
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database
Postoperative adhesions can be prevented by the use of bioabsorbable anti-adhesion barriers. Although the occurrence of po...
Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and Korea
Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and Korea
Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increa...
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology
Early inclusion of Japan in the global development program could be a key factor in reducing the drug lag, making particip...
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics
The use of master protocols allows for innovative approaches to clinical trial designs, potentially enabling new approache...
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?
Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regul...
Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan
Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan
The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigi...
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical prod...
Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Linagliptin is an oral dipeptidyl peptidase DPP‐4 inhibitor, which is indicated for the treatment of Type 2 diabetes...
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis
Immunoglobin light chain (AL) amyloidosis is a rare disease in which a plasma cell dyscrasia leads to deposition of insolu...
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History
The classification of medical devices by the Food and Drug Administration (FDA) involves rigorous scrutiny from specialize...
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Clinical Pharmacy Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi ArabiaMohammed Alnuhait, Abdullah...
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data
Progression-free survival (PFS) is used to evaluate treatment effects in cancer clinical trials. Disease progression (DP) ...
Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections
Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections
Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challe...
An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium
An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium
Accurate and timely reporting of adverse events (AEs) in clinical trials is crucial to ensuring data integrity and patient...
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States
Recent Food and Drug Administration (FDA) draft guidelines are intended to improve representation and formalize the assess...
Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies
Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies
We examined the development strategies of new molecular entities approved during a 10-year period (fiscal years of 2012...
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions
In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a...
Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Pharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, inclu...
Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports
Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports
This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Ara...
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data
Conducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. Th...
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