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A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey
A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey
Clinical outcome assessments (COAs) measure how patients feel or function and can be used to understand which patients exp...
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea
The sales patterns of original drugs after patent expiration in Korea show a relatively high market share and continuous s...
Interim Clinical Trial Data: Who Can See What, and When?
Interim Clinical Trial Data: Who Can See What, and When?
It has long been a basic principle of randomized clinical trials addressing serious outcomes and/or major public health is...
Basic Considerations for the Consistency Evaluation Based on ICH E17 Guideline
Basic Considerations for the Consistency Evaluation Based on ICH E17 Guideline
In the International Council for Harmonisation (ICH) guidance on General Principles for Planning and Design of Multi-Regio...
A Sponsor’s Best Practice and Operating Principles to Manage Data Monitoring Committees
A Sponsor’s Best Practice and Operating Principles to Manage Data Monitoring Committees
The use of data monitoring committees (DMC) to safeguard patients’ safety in clinical trials has evolved over the la...
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students
Youth nicotine addiction is a major public health concern in the United States. Disposable Electronic Nicotine Delivery Sy...
Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities
Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities
This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by i...
Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority
Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority
The Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good Clinical Practice (GCP) to safeguard...
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information
One of the main objectives of pharmacovigilance activities is to confirm unknown adverse drug reactions (ADRs), and data-m...
Risk-Based Quality Management: A Case for Centralized Monitoring
Risk-Based Quality Management: A Case for Centralized Monitoring
Since 2019, the Association of Clinical Research Organizations has conducted a landscape survey of risk based quality mana...
Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer’s Disease
Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer’s Disease
Alzheimer’s disease (AD) is a neurodegenerative disease for which many clinical trials failed to detect treatment ef...
Data Monitoring Committee Reports: Telling the Data’s Story
Data Monitoring Committee Reports: Telling the Data’s Story
A Data Monitoring Committee (DMC) plays a pivotal role in monitoring participant safety and efficacy and overseeing the in...
Research on Core Competency Elements of Clinical Investigators
Research on Core Competency Elements of Clinical Investigators
To construct a competency model for clinical investigators involved in the process of new drug development, providing a re...
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible
‘Risk Management Plan Educational Materials’ (RMP EMs) are additional risk minimization measures (aRMMs) inten...
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials
Over the last few years, many efforts have been made to leverage historical information in clinical trials. Incorporating ...
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information
A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication be...
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods
MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there...
A Global Industry Survey on Post-Approval Change Management and Use of Reliance
A Global Industry Survey on Post-Approval Change Management and Use of Reliance
Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken...
Insights into Early Interactions on Innovative Developments with European Regulators
Insights into Early Interactions on Innovative Developments with European Regulators
The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology devel...
Tips for Accelerating BOIN Design
Tips for Accelerating BOIN Design
During discussions at the Data Science Roundtable meeting in Japan, there were instances where the adoption of the BOIN de...
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries
This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countrie...
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States
We analyzed factors shaping the choice of the lead indication (i.e., cancer type) in the first clinical development projec...
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database
Denosumab is widely used for osteoporosis and cancer treatment. However, hypocalcemia induced by denosumab is a frequent a...
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs
Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its int...
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...
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...
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial
Bayesian borrowing analyses have an important role in the design and analysis of pediatric trials. This paper describes us...
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...
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 ...
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