Therapeutic Innovation & Regulatory Science

Article	Citations
The Use of External Controls in FDA Regulatory Decision Making	53
Real World Evidence in Medical Cannabis Research	37
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design	34
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials	30
Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative	23
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	19
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019	16
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulati	16
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View	16
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	15
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	15
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review	14
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation	14
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters	13
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments	13
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative	13
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry	13
Assessing the Financial Value of Decentralized Clinical Trials	12
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements	12
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	12
Effective Data Sharing as a Conduit for Advancing Medical Product Development	12
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future	12
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities	11
Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?	11
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications	11

New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19	11
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting	11
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	11
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	10
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	10
Drivers of Start-Up Delays in Global Randomized Clinical Trials	10
FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals	10
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	9
Extrapolation as a Default Strategy in Pediatric Drug Development	9
Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes	9
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021	9
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	9
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic	9
Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis	9
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020	9
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016	9
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion	9
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy Groups	9
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial	9
Innovation Pathways in the NHS: An Introductory Review	9
Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies	8
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	8
Bridging the Gap Between RCTs and RWE Through Endpoint Selection	8
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity	8
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle	8
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum	8
Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative	8
Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores	8
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies	7
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development	7
Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies	7
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity	7
Factors Affecting Success of New Drug Clinical Trials	7
Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide	7
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	7
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development	7
The Role of Master Protocols in Pediatric Drug Development	7
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	7
Addressing Bias in Responder Analysis of Patient-Reported Outcomes	7
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform	7
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan	7
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	7
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children	6
Collection of Post-treatment PRO Data in Oncology Clinical Trials	6
Risk-Based Monitoring in Clinical Trials: 2021 Update	6
Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic	6
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives	6
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation	6
Analysis of Pediatric Drug Approval Lag in Japan	6
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring	6

Update of EMA’s Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use	6
Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa	6
Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)	6
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	6
Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017	6
FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science	6
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing	5
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?	5
Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS	5
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines	5
Anti-lung Cancer Marine Compounds: A Review	5
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan	5
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning	5
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims	5
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	5
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation	5
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further	5
Since the Mid-2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to Analyze Their Effectiveness?	5
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	5
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	5
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach	5
Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines	5
Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective	5
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	5
Determining Minimum Wear Time for Mobile Sensor Technology	5
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey	5
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey	5
Text Classification for Clinical Trial Operations: Evaluation and Comparison of Natural Language Processing Techniques	5
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials	5
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration	5
Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study	4
A Tutorial on Modern Bayesian Methods in Clinical Trials	4
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training	4
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA	4
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities	4
Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance	4
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	4
Trends and Characteristics of New Drug Approvals in China, 2011–2021	4
Improving Development of Drug Treatments for Pregnant Women and the Fetus	4
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER	4
Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions	4
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe	4
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy	4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	4
Protocol Deviations: A Holistic Approach from Defining to Reporting	4
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	4
Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015–2019	4
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	4
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development	4
Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial Data	4
Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies	4
Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance	4
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	3
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	3
An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling	3
Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis	3
Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials	3
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice	3
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters	3
Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA	3
U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newl	3
Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy	3
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	3
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans	3
Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development	3
Digital Health Technologies in Pediatric Trials	3
Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays	3
Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Trends, Drivers, and Value of Product Support Activities, Key Performance Indicators, and Other Medical Information	3
MedDRA Labeling Groupings to Improve Safety Communication in Product Labels	3
Opportunities and Risks of UK Medical Device Reform	3
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	3
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials	3
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development	3
Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic	3
Heart Failure Population with Therapeutic Response to Sacubitril/Valsartan, Spironolactone and Candesartan: FDA Perspective	3
Mixed Models for Repeated Measures Should Include Time-by-Covariate Interactions to Assure Power Gains and Robustness Against Dropout Bias Relative to Complete-Case ANCOVA	3
Sample Size Calculation When Planning Clinical Trials with Intercurrent Events	3
The Occurrence of Encephalitis Due to Immune Checkpoint Inhibitors: A Pharmacovigilance Study	3
Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment	3
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	3

A Generalization of the Two Trials Paradigm	3
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing	3
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group	3
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	3
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response	3
Bayesian Strategies in Rare Diseases	3
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	3
Interdisciplinary Safety Evaluation for Learning and Decision-Making	3
Disagreements Between FDA and its Oncologic Drugs Advisory Committee (ODAC)	3
Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer	3
Value of Data Sharing to Advance Drug Development: A Regulatory Perspective	3
Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers	3
The Competency of Clinical Research Coordinators: The Importance of Education and Experience	3
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	2
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	2
The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking	2
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis	2
Safety and Effectiveness of Multiple Switching Between Originators and Biosimilars: Literature Review and Status Report on Interchangeability	2
Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions	2
Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical Trials	2
Digital Tools—Regulatory Considerations for Application in Clinical Trials	2
elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials	2
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	2
Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation	2
Treatment of Death Events in the Analysis of Time to Progression	2
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	2
Risk Prediction of Central Nervous System Infection Secondary to Intraventricular Drainage in Patients with Intracerebral Hemorrhage: Development and Evaluation of a New Predictive Model Nomogram	2
Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic	2
Solution Oligonucleotide APIs: Regulatory Considerations	2
Choosing a Mobile Sensor Technology for a Clinical Trial: Statistical Considerations, Developments and Learnings	2
Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies	2
Emergency Use Authorization for Remdesivir and Its Potential Implications	2
Benchmarking Patient Recruitment and Retention Practices	2
Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites	2
Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000–2018)	2
Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth	2
An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology	2
Risk Management in Drug-Device Combination Product Development	2
Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot	2
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	2
Government Pharmaceutical Development to Address High Prices: Challenges Ahead	2
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels	2
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	2
The Medical Science Liaison Role in Spain: A Survey About the Opinion of HealthCare Professionals	2
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future—An Industry View	2
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	2
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan	2
Graphical Analyses in the Regulatory Evaluation of Gene Therapy Applications	2
Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio	2
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	2
Rebranding Gout: Could a Name Change for Gout Improve Adherence to Urate-Lowering Therapy?	2
Establishing Consensus Understanding of the Barriers to Drug Development in Lupus	2
AI/ML in Precision Medicine: A Look Beyond the Hype	2
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	2
The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications	2
Medical Information Practices Across the Pharma Industry: What Can We Learn from Benchmarking Surveys?	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
A Systematic Review of the Efficacy and Safety of Aspirin When Delivered at Different Medication Times for the Primary and Secondary Prevention of Cardiovascular and Cerebrovascular Diseases	2
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	2
Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol	2
Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects	2
Data-Driven Subgroup Identification in Confirmatory Clinical Trials	2
Characteristics of Drug Intervention Clinical Trials and Scientific Impact of the Trial Outcome: A Bibliometric Analysis Using the Relative Citation Ratio in Non-small Cell Lung Cancer from 2007 to 20	2
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan	1
Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box	1
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	1
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	1
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	1
Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan	1
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation	1
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies	1
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids	1
Bayesian Design for Pediatric Clinical Trials with Binary Endpoints When Borrowing Historical Information of Treatment Effect	1
Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs	1
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	1
The Implementation of the 2020 Roadmap to Promote Good Registration Management (GRM) in APEC Region	1
Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity Issues	1
Accelerating Pediatric Drug Development: A 2022 Special Issue of Therapeutic Innovation & Regulatory Science	1
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	1
Expert Commentary: Diverse Meanings of Regulatory “Convergence”	1
Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI	1
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission	1
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	1
Pharmacometrics: The Already-Present Future of Precision Pharmacology	1
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	1
Key Steps Toward a Promotional Communications Strategy: Collaboration Best Practices for Teams Creating Promotional Materials and Regulatory Colleagues	1
Utility-Based Dose Selection for Phase II Dose-Finding Studies	1
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan	1
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in	1
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	1
Impact of Tumor Assessment Frequency on Statistical Power in Randomized Cancer Clinical Trials Evaluating Progression-Free Survival	1
Spatial-Cluster Signal Detection in Medical Devices Using Likelihood Ratio Test Method	1
phactMI Benchmarking Survey on Content Development and Inquiry Management	1
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	1
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings	1