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Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends
Tuberculosis (TB) remains a major global health challenge, driving the need for innovative approaches in diagnosis and dru...
Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety Devices
Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety Devices
Medical devices used in health care should fulfill the requirements of the technical regulations to protect patient health...
Implementation of Established Conditions and Use of Quality by Design Principles during Drug Development: Status in the US, EU, and Japan. Data from a Survey Conducted by the Japan Pharmaceutical Manufacturers Association (JPMA)
Implementation of Established Conditions and Use of Quality by Design Principles during Drug Development: Status in the US, EU, and Japan. Data from a Survey Conducted by the Japan Pharmaceutical Manufacturers Association (JPMA)
The JPMA conducted a survey among its member companies regarding the use of Established Conditions (ECs) under ICH Q12. EC...
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials
Bristol Myers Squibb (BMS), in collaboration with ZS and Tufts CSDD, recently conducted a detailed evaluation of participa...
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format
In Japan, prescription drug labeling has transitioned to a new structured format aimed at improving clarity and consistenc...
Exploring Diabetes Clinical Trial Participation: A Diverse Group Interview Study
Exploring Diabetes Clinical Trial Participation: A Diverse Group Interview Study
Clinical trial participation is critical for ensuring new medical treatments are safe and effective for all populations. N...
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews
During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 med...
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review
To identify and review scientific evidence from experimental studies utilizing unmanned aerial vehicles (UAVs) to transpor...
Incretin Dominance and Emerging Mechanisms in Obesity Pharmacotherapy: Insights from 275 Registered Clinical Trials (2019–2024)
Incretin Dominance and Emerging Mechanisms in Obesity Pharmacotherapy: Insights from 275 Registered Clinical Trials (2019–2024)
Obesity remains a critical global health challenge, with rising prevalence and a substantial cardiometabolic and psychosoc...
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan
The method of collecting electronic patient-reported outcome (ePRO) data using the bring your own device (BYOD) approach h...
Application of Bayesian Borrowing Methods in Clinical Trials for Children with Type II Diabetes Mellitus
Application of Bayesian Borrowing Methods in Clinical Trials for Children with Type II Diabetes Mellitus
Clinical trials for children with type II diabetes mellitus (T2DM) pose challenges often due to recruitment issues. The va...
A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015–2022
A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015–2022
Legislative initiatives have spurred an increase in pediatric drug development programs. However, some drug products studi...
Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review
Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review
This study explores the revolutionary potential of in-silico clinical trials (ISCTs) in medical device development, emphas...
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial
The Mixed Model for Repeated Measures (MMRM) is widely used in clinical trials, however, its reliance on the Missing at Ra...
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)
Data integrity (DI) has become a cornerstone of regulatory oversight in pharmaceutical manufacturing. The COVID-19 pandemi...
Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective
Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective
European legislation requires Marketing Authorization Holders (MAHs) to continuously monitor Eudravigilance (EV) data and ...
Assessment of Local Pharmaceutical Manufacturing Sector in a Low-income Country: A Descriptive Study
Assessment of Local Pharmaceutical Manufacturing Sector in a Low-income Country: A Descriptive Study
In high-income countries and emerging economies, pharmaceutical manufacturing is a driver for socioeconomic development. I...
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights
Achieving first-cycle approval in Abbreviated New Drug Applications (ANDAs) is a critical goal in the generic drug industr...
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies
In Japan, anticancer drugs are often approved based on the objective response rate (ORR) when the conduct of a confirmator...
Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation
Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation
The United Kingdom (UK)’s regulatory profile is changing following the UK’s exit from the European Union (EU)....
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review
Policy reforms in drug regulation and reimbursement have encouraged drug research and development in China. However, there...
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials
The global drug development regulatory community, through the International Council for Harmonisation (ICH) guidelines for...
Catering the Need of Drug Manufacturing Standard in India: An Update to Indian Pharmacopoeia
Catering the Need of Drug Manufacturing Standard in India: An Update to Indian Pharmacopoeia
India is currently among the top 10 pharmaceutical markets by value and is the third largest by volume in 2024; it manufac...
Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance
Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance
The thalidomide tragedy of the 1960s led to restrictions and limitations in the participation of pregnant women in clinica...
Sponsor- vs. FDA-Initiated Changes to Pediatric Clinical Trial Protocols: A Comparison of Associated Participant Burden
Sponsor- vs. FDA-Initiated Changes to Pediatric Clinical Trial Protocols: A Comparison of Associated Participant Burden
Risks associated with clinical trial participation are a foremost consideration during protocol development whereas trial-...
Optimizing Quality Tolerance Limits Monitoring in Clinical Trials Through Machine Learning Methods
Optimizing Quality Tolerance Limits Monitoring in Clinical Trials Through Machine Learning Methods
The traditional clinical trial monitoring process, which relies heavily on site visits and manual review of accumulative p...
Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives
Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives
This paper describes the planning of a patient preference study for evaluating device features for the subcutaneous (SC) d...
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024
In November 2007, a black box warning was mandated for rosiglitazone in type 2 diabetes mellitus (T2DM) based on an increa...
Toward an Extensible Regulatory Framework for N-of-1 to N-of-Few Personalized RNA Therapy Design
Toward an Extensible Regulatory Framework for N-of-1 to N-of-Few Personalized RNA Therapy Design
The emergence of personalized RNA therapeutics, tailored to individual patients' genetic profiles, offers new hope for...
A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials
A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials
In clinical development, an independent data safety monitoring committee (IDMC) is often established to ensure the test tr...
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