Therapeutic Innovation & Regulatory Science

Article	Citations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	57
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	50
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	38
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	34
Anti-lung Cancer Marine Compounds: A Review	34
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	33
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	31
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	27
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	26
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	26
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	25
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	25
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	22
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	21
Decentralized Clinical Trials in the Development of Drugs and Biological Products	21
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	20
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	19
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	19
Real World Evidence in Medical Cannabis Research	19
Pharmacometrics: The Already-Present Future of Precision Pharmacology	17
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	17
A Generalization of the Two Trials Paradigm	16
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	16
New Estimates on the Cost of a Delay Day in Drug Development	16
Correction: Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	15

A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	15
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	14
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	14
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	14
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	14
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	13
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	13
Open Source Analytics App for Clinical Trials: Letter to the Editor—A Novel App for Insights into Laboratory Data of Clinical Trials	13
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	13
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	13
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans	13
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	12
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	12
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	11
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	11
Japanese Regulatory Considerations for Interoperability of Medical Devices	11
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	11
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	11
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	10
Overdosage Section in US and EU Labeling	10
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	10
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	10
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	10
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	9
Risk Management in Drug-Device Combination Product Development	9
Performance Evaluation of Interim Analysis in Bioequivalence Studies	9
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	9
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	9
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	9
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	9
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	9
Digital Tools—Regulatory Considerations for Application in Clinical Trials	9
Transforming Objective Participatory Patient Advocacy	8
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	8
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Gen	8
Training New DMC Members: A Call to Action	8
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	8
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	8
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan	8
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	8
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	8
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	8
Risk-Based Quality Management: A Case for Centralized Monitoring	8
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	8
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen	7
Statistical Analysis for Rating Scale in Clinical Trials	7
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	7
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	7
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	7

AI/ML in Precision Medicine: A Look Beyond the Hype	7
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	7
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	7
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application	7
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	7
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	6
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	6
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	6
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	6
Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science	6
Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making	6
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	6
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	6
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan	6
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	6
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	6
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	6
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	6
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	6
Cancer Clinical Trial Patients’ Perceptions of Reporting Adverse Events Via an Electronic Platform	6
Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development	6
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	5
Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan	5
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	5
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	5
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020	5
RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises	5
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools	5
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	5
Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease	5
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	5
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	5
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	5
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	5
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	5
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	5
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	5
Bayesian Clinical Trials	5
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	5
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	5
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Application of Meta-analysis to Evaluate Relationships Among ARIA-E Rate, Amyloid Reduction Rate, and Clinical Cognitive Response in Amyloid Therapeutic Clinical Trials for Early Alzheimer’s Disease	4
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	4
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations	4
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance	4
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	4
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward	4
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
Digital Health Technologies in Pediatric Trials	4
Treatment of Death Events in the Analysis of Time to Progression	4
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	4
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	3
Basic Considerations for the Consistency Evaluation Based on ICH E17 Guideline	3
The Path To Tarlatamab Approval: Leveraging Innovative Strategies and Global Regulatory Pathways	3
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	3
Correction: The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	3
Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development	3
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data	3
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	3
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	3
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions	3
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials	3
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials	3
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers	3
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	3
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa	3
Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences	3
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapie	3

The Predictive Individual Effect for Survival Data	3
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023	3
Expanding Pharmaceutical Access Via Over the Counter Drugs	3
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners	3
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation	3
Interim Clinical Trial Data: Who Can See What, and When?	3
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials	3
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results	3
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials	3
Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach	3
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	2
Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs	2
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information	2
Assessment of the State of Pharmacovigilance in Secondary Hospitals in the Federal Capital Territory of Nigeria, Using WHO Pharmacovigilance Indicators	2
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	2
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups	2
Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefi	2
Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol	2
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	2
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	2
Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box	2
Advancing AI Ethics Frameworks in Drug Development: Global Applicability, Practical Challenges, and Dynamic Governance	2
Publisher Correction: Survey Result for E-labeling Initiatives in Asia	2
Pediatric Market Access: A Qualitative Study	2
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History	2
Solution Oligonucleotide APIs: Regulatory Considerations	2
Semantic Search of FDA Guidance Documents Using Generative AI	2
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space	2
Analysis of Off-target Effects and Risk Assessment Leading from Preclinical to Clinical Trials of Gene-edited Therapeutic Products	2
Review of the European Union Clinical Trials Regulation: Key Early Learnings from the United Kingdom Drug Information Association Medical Writing Committee	2
A Flexible Ensemble Learning Method for Survival Extrapolation	2
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials	2
Call for Papers: The Inflation Reduction Act and Its Impact on Innovation, Access, and Affordability	2
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	2
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	2
Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method	2
Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data	2
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids	2
Extrapolation as a Default Strategy in Pediatric Drug Development	2
The Medical Information Scientific Process: Define, Research, Evaluate, Synthesize, and Share (DRESS)	2
Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials	2
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	2
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	2
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics	2
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China	2
Public Perspectives on Direct-to-Consumer Testing Oversight	2
Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation	2
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video	2
Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	2
Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies	2
An Extended Framework of Multiple Testing in Group Sequential Design	2
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	2
Evaluation of FDA Labeling Changes Related to PREA Safety–Waivers	2
Incorporating Patient Input into the Target Product Profile	2
The Role of Master Protocols in Pediatric Drug Development	2
Examining Endpoint Concordance in Clinical Trials and Real-World Clinical Practice to Advance Real-World Evidence Utilization	2
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-Cen	2
Quantifying Site Burden to Optimize Protocol Performance	2
Factors Affecting Success of New Drug Clinical Trials	2
Survey Result for E-labeling Initiatives in Asia	2
Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act	1
Draft Guideline for Industry to Manage Drug Shortages in Japan	1
Correction to: Response to the Letter to the Editor by Koneswarakantha and Ménard	1
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review	1
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	1
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines	1
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap	1
Research on Core Competency Elements of Clinical Investigators	1
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8	1
Data Monitoring Committee Reports: Telling the Data’s Story	1
Trends and Characteristics of New Drug Approvals in China, 2011–2021	1
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	1
The Adoption and Use of Artificial Intelligence and Machine Learning in Clinical Development	1
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan	1
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	1
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics	1
Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies	1
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches	1
Leveraging Synthetic Data to Facilitate Research: A Collaborative Model for Analyzing Sensitive National Cancer Registry Data in England	1
Navigating the Evolving Eurasian Economic Union’s Pharmaceutical Landscape: Streamlining Drug Registration for Market Access	1
Leveraging Real-World Data in Safety Signal Assessment	1
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis	1
Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan	1
Assessing the Financial Value of Decentralized Clinical Trials	1
On the Application of Artificial Intelligence/Machine Learning (AI/ML) in Late-Stage Clinical Development	1
Key Findings from Pharmacovigilance Inspections in Saudi Arabia’s Pharmaceutical Sector	1
Delivering Digital Health Solutions that Patients Need: A Call to Action	1
First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA	1
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective	1
Efficient Risk Mitigation Planning for a Clinical Trial	1
An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling	1
The Data Monitoring Committee: A Collective or a Collection?	1
Adaptation of the WOMAC for Use in a Patient Preference Study	1
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019	1
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	1