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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...
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials
Patient-reported outcomes (PROs) are important measures of efficacy in the context of clinical trials but are sometimes id...
Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development
Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development
Guideline for Good Clinical Practices - International Conference of Harmonization. https://database.ich.org/sites/default/...
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support
Following the largest reorganization in its history, the U.S. Food and Drug Administration (FDA) is now working to moderni...
Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical Trials
Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical Trials
Lack of long-term safety data for the AYA population has been identified as a key area that reduces enrolment of AYA in ad...
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, espe...
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...
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...
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...
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...
Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan
Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan
The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigi...
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical prod...
Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Pharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, inclu...
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States
Recent Food and Drug Administration (FDA) draft guidelines are intended to improve representation and formalize the assess...
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