SCI时时刷

search
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...
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...
Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia
Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia
Drug approval lag is the time difference for new medicine to obtain marketing authorization approval in the study country ...
Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe
Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe
Real-World Evidence (RWE), which has historically been used to support post-approval safety studies, has recently gained a...
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks and remediating em...
Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework
Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework
The International Council on Harmonisation E8 Guidance Revision 1 (ICH E8(R1)) calls for creating a Culture of Quality tha...
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework
While industry and regulators’ interest in decentralized clinical trials (DCTs) is long-standing, the Covid-19 pande...
The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power
The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power
In this note, we express our viewpoint regarding power considerations, via simulation studies, in clinical study design us...
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies
Competency-based education has been commonly used to enhance the healthcare workforce for some time. A translational disci...
Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting
Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting
The past years have sharpened the industry’s understanding of a Quality by Design (QbD) approach toward clinical tri...
Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method
Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method
Multiple criteria decision analysis (MCDA) and stochastic multi-criteria acceptability analysis (SMAA) in their current im...
Quantifying Site Burden to Optimize Protocol Performance
Quantifying Site Burden to Optimize Protocol Performance
The increase in protocol complexity and the resulting rise in the effort required by investigative sites to implement prot...
Aggregate IND Safety Reporting for Smaller Companies and Programs
Aggregate IND Safety Reporting for Smaller Companies and Programs
The United States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) Final Rule (US FDA, Final rule: I...
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 ...
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals
Health care inequity includes the lack of adequate representation of various populations in clinical trials. Government, a...
An Evaluation of the Swissmedic Regulatory Framework for New Active Substances
An Evaluation of the Swissmedic Regulatory Framework for New Active Substances
Swissmedic is a major regulatory agency that has been benchmarking its timelines for 20 years. To better understa...
Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century
Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century
The guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ...
Pediatric Market Access: A Qualitative Study
Pediatric Market Access: A Qualitative Study
This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutio...
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...