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Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
As cancer has become better understood on the molecular level with the evolution of gene sequencing techniques, considerat...
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, espe...
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the ...
Paediatric Drug Development in Japan: Current Status and Future Challenges
Paediatric Drug Development in Japan: Current Status and Future Challenges
Until around 2000, the number of medicinal products labelled for paediatric use was limited worldwide. Regulatory measures...
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
Post-marketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the ...
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
The lack of label information for the pediatric population has been a global issue, leading to the introduction of several...
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
The risk-based approach (RBA) of clinical trial was first introduced in 2011–2012. RBA necessitates implementing ris...
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...
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...
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...
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...
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
Cite this articleAlnuhait, M., Alshammari, A., Alharbi, M. et al. Correction: Comparative Assessment of Drug Lag for Appro...
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...
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 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...
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...
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...
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) ...
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...
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...
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...
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 ...
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
Accelerated approval (AA) program expedites access to promising drugs for life-threatening conditions, particularly in onc...
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies
Dose optimization is a focal point of many US Food and Drug Administration (FDA) drug approvals. We sought to understand t...
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model
To develop a machine learning (ML)-based model for predicting the addition of clinically significant adverse reaction (CSA...
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced ...
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment
Limited evidence related to the safety or efficacy of medicines in pregnancy and during breastfeeding is available to info...
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits
In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated i...
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy
Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The...
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations
The Access Consortium New Active Substance Work-Sharing Initiative, or “Access” for simplicity, allows regulat...
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