DIA / DRUGINFORMATIONJOURNAL

Drug Information Journal - November 2009

Thu, 05 Nov 2009 13:10:40 -0500

Your digital edition of Drug Information Journal - November 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - November 2009
- Table of Contents
- Guest Editor’s Note: 20th Anniversary Special Section on Medical Communications
- Surveying Medical Information Across Europe: The Present and the Future
- Auditing Medical Information Services Across Western Europe: A Cost-Effective Approach
- A Practical Approach to Evidence-Based Medicine for the Medical Communications Professional
- The Changing Roles of Medical Communications Professionals: Evolution of the Core Curriculum
- Surveys of Medical Liaison Practices Across the Pharmaceutical Industry: A Review
- Results of a Qualitative Market Research Study Evaluating the Quality of Medical Letters
- Historical Perspective of Technologies Used in Medical Communications, Past, Present, and Future
- Planning and Executing Response-Adaptive Learn-Phase Clinical Trials: 1. The Process
- Planning and Executing Response-Adaptive Learn-Phase Clinical Trials: 2. Case Studies
- Evaluating REMS Tools: Issues in Survey Design
- A Matrix to Determine Health Economic Viability Throughout Product Development: A Pharmaceutical Industry Perspective
- The Current Situation of Oncology Drug Lag in Japan and Strategic Approaches for Pharmaceutical Companies
- Author Index to Volume 43, 2009
- Key Word Index to Volume 43, 2009

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Drug Information Journal - September 2009

Thu, 10 Sep 2009 14:54:35 -0400

Your digital edition of Drug Information Journal - September 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - September 2009
- Contents
- Three Persistent Issues in Analysis of Clinical Trials Involving Diagnostic Contrast Agents
- Compliance Analysis as Additional Evidence for Efficacy in Clinical Trials
- Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development
- Unconditional Exact Tests for Dichotomous Data in the Comparison of Two Treatments With One Control Group
- A Study of the Classical Asymptotic Noninferiority Test for Two Binomial Proportions
- Qualified Statisticians in the European Pharma Industry: Present and Future Directions
- Weibull Failure-Time Mixture Models for Evaluating Efficacy in the Presence of a Biomarker
- Repeated Measures Analyses in Clinical Trials With Titration Visits
- Constant Vigilance: The Role of Pharmaceutical Companies in Medicine Safety
- Perception of Risk Through Phases of Drug Research and Development
- Good Pharmacovigilance Practice
- Review of Targeted Regulatory Writing Techniques

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Drug Information Journal - July 2009

Wed, 08 Jul 2009 08:51:33 -0400

Your digital edition of Drug Information Journal - July 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - July 2009
- Contents
- Content Analysis of FDA Warning Letters toManufacturers of Pharmaceuticals and Therapeutic Biologicals for Promotional Violations
- Electronic Common Technical Document Implementation in Japan
- Editorial: Dealing With the Missing Data Challenge in Clinical Trials
- Incomplete Data in Clinical Studies: Analysis, Sensitivity, and Sensitivity Analysis
- Comment: Incomplete Data in Clinical Studies:Analysis, Sensitivity, and Sensitivity Analysis
- A Commentary on G. Molenberghs’s Review ofMissing Data Methods
- Discussion: “Incomplete Data in Clinical Studies:Analysis, Sensitivity, and Sensitivity Analysis”
- Global Sensitivity Analysis for Randomized Trials With Informative Dropout: A Semiparametric Perspective
- Incomplete Data in Clinical Studies: Analysis,Sensitivity, and Sensitivity Analysis—Rejoinder
- Conceptual Considerations Regarding Endpoints,Hypotheses, and Analyses for IncompleteLongitudinal Clinical Trial Data
- Effective Strategies for Maintaining ResearchParticipation in Clinical Trials
- A Note on Missing Data in Noninferiority Trials
- Sensitivity Analysis of Missing Data: Case Studies Using Model-Based Multiple Imputation
- Minimizing Missing Data in Clinical Trials: Design, Operation, and Regulatory Considerations
- Drug Development Portfolio and Spending Practices After Mergers and Acquisitions
- Bringing Patient Recruitment Into Our Digital World
- Assessing Medical Information Needs Via an Internet-Based Survey
- 2009 Annual Meeting Student Poster Abstracts

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Drug Information Journal - May 2009

Thu, 07 May 2009 16:29:36 -0400

Your digital edition of Drug Information Journal - May 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - May 2009
- Contents
- Continuing Education
- A Robust Methodological Approach for ReplacingGlobal Electronic Document Management
- Emerging Markets and Emerging Agencies: A Comparative Study of How Key Regulatory Agenciesin Asia, Latin America, the Middle East, and Africa Are Developing Regulatory Processes and Review Models for New Medicinal Products
- Pharmaceutical Product Liabilities: A Review ofCurrent Status and Future Trends
- National Center of Excellence for Clinical Trials and Research at National Taiwan University Hospital
- Assessment of Customer Satisfaction With VerbalResponses Provided by a Pharmaceutical Company’s Third-Party Medical Information Call Center
- Generic Versus Branded Pharmaceutical StrategicConsiderations: An Irish Focus With GlobalPerspective
- Development of a Content Uniformity Test Suitable for Sample Sizes Between 30 and 100
- Editor’s Note
- An Experimental Model of Regulatory Science inAsia: Center for Drug Evaluation in Taiwan
- APEC Pharmaceutical Evaluation Report (PER)Scheme: A Regional Solution for Global DrugDevelopment
- The Critical Path Program in Taiwan
- A Proposal for a Parallel Submission Process forNew Drug Applications and Health TechnologyAssessment in Taiwan: A Win-Win Solution
- Harmonizing East Asia: The Evolution of DIA inJapan and Its Impact on East Asia
- Industry Efforts on Simultaneous GlobalDevelopment
- Nurturing the Clinical Research Leaders ofTomorrow
- An Overview of Bridging Study Evaluation inTaiwan
- 8th Middle East Regulatory Conference

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Drug Information Journal - March 2009

Thu, 26 Feb 2009 10:05:28 -0500

Your digital edition of Drug Information Journal - March 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - March 2009
- Table of Contents
- How to Write a Better Manuscript
- New Web Tools to Improve PubMed Searches for the Biomedical Community
- A Pharmaceutical Alliance in Medical Information: Lessons Learned in the Life Cycle
- Reusing Clinical Protocol Content to Improve R&D Productivity
- Local Laboratory Reference Intervals in Clinical Trials
- Establishing an Industry-Based Drug Information Pharmacy Student Rotation
- Knowledge Innovation and Clinical Operational Excellence
- Trends in Meta-analysis
- A Multiple Comparisons Procedure for Comparing All Arms in Three-Arm Clinical Trials
- Sampling Uncertainty in the Cost-Effectiveness Evaluations and Guidance Given by the Existing Pharmacoeconomic Guidelines: A Question to Be Considered
- Clinical Trial Registries: A Survey of Patient Advocate Group Perceptions
- Factors Associated With Multiple FDA Review Cycles and Approval Phase Times
- 2009 EuroMeeting Student Poster Abstracts

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Drug Information Journal - January 2009

Thu, 08 Jan 2009 16:46:42 -0500

Your digital edition of Drug Information Journal - January 2009 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - January 2009
- Table of Contents
- Editor’s Note
- Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences
- A Noninferiority Test for Treatment-by-Factor Interaction With Application to Bridging Studies and Global Trials
- The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation
- Collaboration Between Japan and Other Asian Countries in New Drug Development: Japanese Industry Perspective
- Bridging Study Versus Prespecified Regions Nested in Global Trials
- The Role of the Asia-Pacific Region in Global Drug Development Strategy
- Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea
- Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development Over the Last Five Years
- Clinical Trials in Southeast Asia: An Update
- Updates on IND Process and Clinical Trials Status in Taiwan
- Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them
- Stringent Laws and Regulations for Dietary Supplements
- Statistical Validation of Traditional Chinese Diagnostic Procedures
- Nonclinical Testing of Vaccines: Report From a Workshop
- A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

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Drug Information Journal - November 2008

Tue, 28 Oct 2008 14:33:51 -0400

Your digital edition of Drug Information Journal - November 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - November 2008
- Contents
- An Investigation of Proportion Designs Based on a Molecularly Targeted Endpoint
- The Importance of Medical Innovation in an Investigator’s Decision to Take Part in Clinical Trials
- Confirm and Explore: A Stepwise Approach to Clinical Study Designs
- Publishing a Drug Information Bulletin: Experiences From a Developing Country
- Opening the Black Box of Pharmaceutical Patent Value: An Empirical Analysis
- Legal Requirements for Drug Information Resources Maintained by Pharmacies
- A Comparative Study of the Communication of Drug Safety Information by Governmental Agencies in Japan and Western Countries: The Case of Asthma Medications
- Accounting for Interim Analyses in the Assessment of Program Expected Net Present Value
- A Noninferiority Margin for Acne Lesion Counts
- Statistical Test for Ordered Categorical Data in Clinical Trials
- How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?
- A Review of Pharmacoepidemiology and Therapeutic Risk Management
- Author Index to Volume 42, 2008
- Key Word Index to Volume 42, 2008

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Drug Information Journal - September 2008

Fri, 29 Aug 2008 15:48:34 -0400

Your digital edition of Drug Information Journal - September 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - September 2008
- Table of Contents
- VigiBase, the WHO Global ICSR Database System: Basic Facts
- Good Practices for Handling Adverse Events Detected Through Patient Registries
- Sample Size Algorithms in Clinical Trials
- Urn-Based Response Adaptive Procedures and Optimality
- Some Guidelines for Interim Data Review of Clinical Trial Data
- Implementation of a Phase 1 Adaptive Clinical Trial in a Treatment of Type 2 Diabetes
- On the Amendments of China’s Provisions for Drug Registration
- Biosimilars: A Regulatory Review
- Development and Establishment of Good Review Practices for Drug Products in Korea
- The Effects of Physicians’ Financial Incentives on the Effectiveness of Taiwan’s Outpatient Drug Copayment Policy
- Pharmacogenetics: From Bench Science to the Bedside
- Report of Task Force II: Best Practices in the Use of Medical Imaging Techniques in Clinical Trials: Consensus from a Public Meeting
- Book Review

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Drug Information Journal - July 2008

Mon, 23 Jun 2008 09:53:36 -0400

Your digital edition of Drug Information Journal - July 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - July 2008
- Contents
- Continuing Education: Coordination Data Monitoring Committess and Adaptive Clinical Trial Designs
- Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials
- Current Statistical Requirements for Phamaceutical Clinical Trials in China
- Adaptive Design and Decision Analysis - Companions for Transforming Clinical Development
- Conditional Exact Tests for Dichotomous Data in the Comparison of Two Treatments With One Control Group
- Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors
- Evaluation of Some Alternative Designs for Phase 2 Mulitple Sclerosis Trials - A Simulation Study
- Introduction
- Regulatory Requirements and Informed Consent
- Consent Comprehension in the 21st Century: What Is Missing?
- Consent Forms, Lower Reading Levels, and Using Flesch-Kincaid Readability Software
- 2008 Annual Meeting Student Poster Abstracts
- African Regulatory Conference

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Drug Information Journal - May 2008

Mon, 05 May 2008 12:37:43 -0400

Your digital edition of Drug Information Journal - May 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - May 2008
- Contents
- Safety Signals Using Proportional Reporting Ratios From Company and Regulatory Authority Databases
- Pharmacokinetic and Pharmacodynamic Characterization of Non-antiarrhythmic QT- Prolonging Drugs Associated With Torsades de Pointes
- Special Section: Benefit:Risk Evaluation in Clinical Trials
- Measures for Conducting Comparative Benefit:Risk Assessment
- A Perspective on Characterizing Benefits and Risks Derived From Clinical Trials: Can We Do More?
- The GSK Clinical Study Results Database: Site Utilization Metrics for a Large Public Database
- A Two-Stage Design for Drug Screening Trials Based on Continuous Endpoints
- Drug Information Availability and Preferences of Health Care Professionals in Illinois: A Pilot Survey Study
- Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs
- Patient Protection and Access to Innovative Medicinal Products in the European Union

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Drug Information Journal - March 2008

Mon, 18 Feb 2008 09:04:29 -0500

Your digital edition of Drug Information Journal - March 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - March 2008
- Table of Contents
- The Impact of Incorporating Clinical Relevance on the Feasibility of Clinical Trials
- Sample Size Requirements for Clinical Trials With Repeated Binary Outcomes
- Exact Tests for Epidemiological Risks Under Independent Negative Binomial Sampling for Rare Events in Clinical Trials
- Getting Better Clinical Trial Data: An Inverted Viewpoint
- “Substantial Evidence” From a Replicated Secondary Analysis, Followed by a Single Prospective Confirmatory Study
- An Approach to Rationalize Partitioning Sample Size Into Individual Regions in a Multiregional Trial
- Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations
- Pharmaceutical and Analytical Quality Control Services: Ownership or Outsourcing—A South African Case Study
- Metrics Implementation in an Industry-Based Medical Information Department and Comparison to Metrics Tracked Within Other Industry- Based Medical Information Departments
- Mega Mergers: A Systematic Approach to the Integration of Two Medical Information Departments
- Monitoring Clinical Trial Data Using an Unblinded Industry Statistician
- Student Poster Abtracts

Drug Information Journal - January 2008

Fri, 04 Jan 2008 11:20:57 -0500

Your digital edition of Drug Information Journal - January 2008 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - January 2008
- Table of Contents
- Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices
- Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper
- Best Practices for Special Protocol Assessment
- Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper
- A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments
- Vector Analysis to Detect Hepatotoxicity Signals in Drug Development
- Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity
- Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA
- Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions
- Handbook of Pharmaceutical Public Policy
- Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons
- On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints
- International Symposium on Adaptive Clinical Trial Designs

Drug Information Journal - November 2007

Thu, 01 Nov 2007 14:21:12 -0400

Your digital edition of Drug Information Journal - November 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Drug Information Journal - November 2007
- Table of Contents
- Practical Application of the Continual Reassessment Method to a Phase I Dose-Finding Trial in Advanced Breast Cancer
- Subject Numbers and Placebo Outcome Variability in Clinical Trials of New CNS Medications
- Optimal Failure-Success Response-Adaptive Designs for Binary Responses
- A Note on Stratification in Clinical Trials
- Interpretation of a Self-Esteem Subscale for Erectile Dysfunction by Cumulative Logit Model
- Data Monitoring in Clinical Trials Using Prediction
- Product Launch and the Strategies, Processes, and Operations of Medical Affairs to Support Start-up Companies
- The Drug Information Center at the Manipal Teaching Hospital—Going Beyond Drug Information
- Identifying Safety Indicators of New Drug Safety Monitoring Programme (SMP) in Thailand
- Online Signal Management: A Systems-Based Approach That Delivers New Analytical Capabilities and Operational Efficiency to the Practice of Pharmacovigilance
- Guide to Paediatric Clinical Research
- Author Index to Volume 41, 2007
- Key Word Index to Volume 41, 2007

Drug Information Journal - September 2007

Tue, 04 Sep 2007 17:14:34 -0400

Your digital edition of Drug Information Journal - September 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Table of Contents
- Biomarker Editorial: The Many Lives of the Biomarker
- Implementation of a Biomarker Into Drug Development: Example of Identifying the Right Imaging “Tool” for an Oncology Study
- Imaging Biomarker Applications in Oncology Drug Development
- Molecular Biomarkers
- A Regulatory Perspective on Validation of Surrogate Endpoints
- Interrater Reliability for Multiple Raters in Clinical Trials of Ordinal Scale
- Notes on Test Equality in Stratified Noncompliance Randomized Trials
- Sex Differences in QT Interval Variability and Implication on Sample Size of Thorough QT Study
- Some Comments on Improving Collaboration Skills of the Statistician on a Drug Development Team
- Using Data Mining to Predict Safety Actions From FDA Adverse Event Reporting System Data
- The Demographic, Practice, and Prescribing Characteristics of US Clinical Investigators
- The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis
- Development of an Established Name: Analyzing Stem Based United States Adopted Naming
- How to Improve Complex Drug Development? A Critical Review of FDA Advisory Meetings
- A Statistician’s Viewpoint of Responders in the Treatment of Neuropathic Pain

Drug Information Journal - July 2007

Wed, 27 Jun 2007 20:58:10 -0400

Your digital edition of Drug Information Journal - July 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- C O N T I N U I N G E D U C AT I O N
- D R U G I N F O R M AT I O N
- P H A R M A C O E C O N O M I C S
- B I O S TAT I S T I C S & A N A LY S I S

Drug Information Journal - May 2007

Mon, 30 Apr 2007 11:48:06 -0400

Your digital edition of Drug Information Journal - May 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Editorial Board
- Table of Contents
- Prescription Drug Advertising and Promotion: Learnings From Recent Food and Drug Administration Warning Letters
- A Comparison of the Drug Review Process at Five International Regulatory Agencies
- Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe
- Potential Predictors of Placebo Response: Lessons From a Large Database
- Revolutionizing the Role of Quality Assurance in Clinical Trials
- Introduction
- The Probability of Registrational Success
- The 505(b)(2) New Drug Application
- Perspective on Quality Risk Management of Pharmaceutical Quality
- Special Section on Clinical Research Standards Introduction
- Toward a Comprehensive CDISC Submission Data Standard
- A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model
- Data Standards: At the Intersection of Sites, Clinical Research Networks, and Standards Development Initiatives
- Controlled Terminology for Clinical Research: A Collaboration Between CDISC and NCI Enterprise Vocabulary Services
- 7th Middle East Regulatory Conference (MERC)
- Student Poster Abstracts
- Book Review

Drug Information Journal - March 2007

Fri, 09 Mar 2007 10:14:44 -0500

Your digital edition of Drug Information Journal - March 2007 is available now. Clicking on the Table of Contents will deliver you directly to that page of your issue. Thank you for reading!

- Table of Contents
- Guest Editorial: DIA/HESI/SAPS Conference on Environmental Risk Assessment of Human Medicines
- Exposure to Pharmaceuticals Present in the Environment
- Environmental Effects of Human Pharmaceuticals
- Environmental Assessment for Human Medicines in the European Union
- Environmental Assessment of Human Pharmaceuticals in the United States of America
- Environmental Assessment of Pharmaceuticals in Canada: A Regulatory Perspective
- Regulations and Guidelines on Human Health Products in Japan
- Assessing Environmental Impacts of Veterinary Products: Lessons From VICH
- A Voluntary Environmental Classification System for Pharmaceutical Substances
- Summary of Workshop on Fate of Pharmaceuticals in the Environment
- Workshop on the Use of Modeling and Monitoring in the Environmental Risk Assessment of Human Medicines
- Summary of Workshop on Use of Data Developed During Drug Development for Read Across to Environmental Analyses
- Summary of Workshop on Environmental Assessment of Human Medicines: Development and Use of Aquatic Toxicity Data
- Summary of Workshop on Mixtures
- Development, Implementation, and Validation of a Capacity Management System
- EWOC 2.0: Interactive Software for Dose Escalation in Cancer Phase I Clinical Trials
- Pharmaceutical Manufacturing Efficiency, Drug Prices, and Public Health: Examining the Causal Links
- An Assessment of Preparation Methods and Personnel Requirements in a Medical Information Department During Product Launch
- Clinical Research Nurses: Roles and Qualifications in South Korea
- Can Medicare Draw Lessons From Dutch Experience With a National Formulary?
- Student Poster Abstracts