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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...
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...
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...
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...
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...
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...
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...
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...
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients ar...
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study
Potentially harmful excipients (PHEs) for children have been reported and the need for information collection has been adv...
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) reno...
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
To better understand the nature of Non-Core procedures and derive new insight into protocol simplification and optimizatio...
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device
The COVID-19 pandemic forced industry and national regulatory authorities (NRAs) to think about innovative ways to ensure ...
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical pr...
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China
In order to meet the unmet needs of rare disease patients in China, importing orphan drugs is an important way. The object...
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
The US Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program is intended to facilitate and e...
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?
Authors and AffiliationsDaiichi Sankyo, Inc., 211 Mount Airy Road, Basking Ridge, NJ, 07920, USATerry Katz MSContego Medic...
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space
The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 32 pharmaceutical com...
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and developm...
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
Neurodegenerative diseases cause developmental delays and loss of milestones in infants and children. However, scalable ou...
Global Postmarket Pharmacovigilance: A Generic Drug Perspective
Global Postmarket Pharmacovigilance: A Generic Drug Perspective
Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic ...
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka
Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which...
Direct-to-Consumer Genetic Testing: A Comprehensive Review
Direct-to-Consumer Genetic Testing: A Comprehensive Review
Emerged in the early 2000s, direct-to-consumer (DTC) genetic testing has helped consumers access and understand their gene...
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence
The nature of alpha-D-mannose—natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing uri...
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement
Master protocols (MPs) are an important addition to the clinical trial repertoire. As defined by the U.S. Food and Drug Ad...
Landscape Analysis of Generic Availability for Oncologic Drugs
Landscape Analysis of Generic Availability for Oncologic Drugs
Improving generic drug development in oncology is a key long-term goal in providing safe, effective, and affordable care t...
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways
Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory to...
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