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Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential Outcomes
Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential Outcomes
Non-randomized comparative studies are often used to compare treatment effects between an investigational product and a co...
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has partnered with the Centre for Innovation in Regulatory ...
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap
Various initiatives and guidelines exist to support patient engagement (PE) throughout the lifecycle of a medicinal produc...
Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After Approval
Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After Approval
A Japanese risk management plan (RMP) is a proactive planning tool for managing safety concerns (important identified risk...
Characterizing Gene Therapy Medicinal Products Post-Marketing Safety Reports Based on WHO Pharmacovigilance Database, VigiBase
Characterizing Gene Therapy Medicinal Products Post-Marketing Safety Reports Based on WHO Pharmacovigilance Database, VigiBase
Safety assessments of gene therapy medicinal products (GTMPs) require comprehensive data collection from a variety of sour...
Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies–Experiences, Expectations and Best Practices from Health Technology Developers
Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies–Experiences, Expectations and Best Practices from Health Technology Developers
Early health technology assessment (HTA) advice provides value to pharmaceutical companies during drug development by iden...
Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials
Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials
Time-to-event endpoints, such as progression free survival (PFS) and overall survival (OS), are critical in assessing ther...
Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan
Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan
To describe the temporal trends in the prescription of biologics in Japan, with additional analysis focusing on switching ...
Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products Identification
Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products Identification
The global pharmaceutical market includes a wide range of medicinal products, which makes it difficult to achieve consiste...
Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)
Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)
The rapid advancement of cell and gene therapies (CGT) in the past ten years has inspired biopharmaceutical companies, bio...
Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination Products
Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination Products
The amendments to the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E8 guidelines were introd...
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support
Cardiovascular and oncology trials increasingly require large sample sizes and long follow-up periods. Several approaches ...
Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews
Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews
In the evolving landscape of clinical research, platform trials have emerged as a revolutionary model, initially designed ...
Master Protocols: A Promising Approach to Accelerate Drug Development in Rare Kidney Diseases
Master Protocols: A Promising Approach to Accelerate Drug Development in Rare Kidney Diseases
Kidney diseases have been a highly challenging area for new drug development because of traditional requirements for reach...
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
Personalized cancer treatment using combination therapies offers substantial therapeutic benefits over single-agent treatm...
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...
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