Drug Safety

A collection of articles that are relevant to drug safety professionals.

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Pharmaceutical Medicine

The definitive guide to the multidisciplinary specialty of pharmaceutical medicine, encompassing scientific, medical and related activities in the discovery, development, evaluation,...

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Showing 1-30 of 30 articles

Statistical Signal Detection Algorithm in Safety Data: A Proprietary Method Compared to Industry Standard Methods
Eugenia Bastos
Jeff K. Allen
Jeff Philip
Original Research Article 13 July 2024 Pages: 321 - 329
Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria
Uchenna Geraldine Elemuwa
Fraden Bitrus
Christiana Mojisola Adeyeye
Original Research Article 06 May 2024 Pages: 251 - 259
Why Oncology Global Safety Teams Should Develop the Safety Section of the Study’s Target Product Profile (TPP)
Michael E. Kieffer
Current Opinion 27 February 2024 Pages: 97 - 108
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Carolyn Sweeney
Alicia Gilsenan
Federica Pisa
Original Research Article Open access 31 January 2024 Pages: 145 - 156
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Anadil Javaid
Catherine Bennett
Lavinia Spain
Review Article Open access 09 January 2024 Pages: 25 - 38
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Laurie J. Zografos
Elizabeth Andrews
Kiliana Suzart-Woischnik
Original Research Article Open access 05 December 2023 Pages: 63 - 73
Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems
Gandi Rayón-Ramírez
Salvador Alvarado-López
Jorge Alcocer-Varela
Leading Article 07 October 2023 Pages: 425 - 437
Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines
Marion Mueller
Joseph Peakin
David J. Lewis
Review Article 18 August 2023 Pages: 439 - 449
Correction to: The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities
Gita A. Toyserkani
Joann H. Lee
Esther H. Zhou
Correction 07 August 2023 Pages: 355 - 355
Recognition of Coroners’ Concerns to Prevent Future Deaths from Medicines: A Systematic Review
Robin E. Ferner
Richard Brittain
Jeffrey K. Aronson
Systematic Review 08 July 2023 Pages: 357 - 363
The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities
Gita A. Toyserkani
Joann H. Lee
Esther H. Zhou
Leading Article 08 July 2023 Pages: 349 - 353
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
Andriani C. Patera
Julie Maidment
Ken Twomey
Current Opinion Open access 26 April 2023 Pages: 183 - 202
Value and Implementation of the Aggregate Safety Assessment Plan
Barbara A. Hendrickson
Anupam Agarwal
Lothar Tremmel
Current Opinion 19 April 2023 Pages: 171 - 181
The Use of Artificial Intelligence in Pharmacovigilance: A Systematic Review of the Literature
Maribel Salas
Jan Petracek
Tina Bostic
Systematic Review 29 July 2022 Pages: 295 - 306
Utilizing Deep Learning for Detecting Adverse Drug Events in Structured and Unstructured Regulatory Drug Data Sets
Benjamin M. Knisely
Qais Hatim
Monifa Vaughn-Cooke
Original Research Article 24 July 2022 Pages: 307 - 317
A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment
Tim Sullivan
Magnus Nord
Richard P. Hermann
Current Opinion Open access 04 July 2022 Pages: 215 - 222
Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research
Hu Li
Francis Mawanda
Stephen Motsko
Original Research Article Open access 04 July 2022 Pages: 247 - 259
Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions
Max Waschbusch
Lisa Rodriguez
Shuai S. Yuan
Current Opinion 03 July 2022 Pages: 201 - 213
An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach
Clare Lavery
Joanne Emmott
Louise Woodward
Original Research Article Open access 20 June 2022 Pages: 233 - 245
Dispositions and Causality Assessment in Pharmacovigilance: Proposing the Dx3 Approach for Assessing Causality with Small Data Sets
Rani Lill Anjum
Rebecca E Chandler
Elena Rocca
Current Opinion Open access 29 April 2022 Pages: 153 - 161
Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder
Kalindi Hapani
Nipa Parikh
Harshil Patel
Original Research Article 13 April 2022 Pages: 173 - 188
Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns
Julia Elvira Johanna Holm
Jan Gustav Ruppert
Samuel David Ramsden
Original Research Article Open access 31 January 2022 Pages: 33 - 46
Digital Additional Risk Minimization Measures: An Exploratory Study Using Qualitative Feedback from Healthcare Professionals and Patients Across Six Countries
Barbara Da Silva-Tillmann
Marie-Claire Wilson
Cheryl Renz
Short Communication 08 January 2022 Pages: 21 - 32
Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union
Hina Patel
Thanh G. N. Ton
Nawab Qizilbash
Original Research Article Open access 07 December 2021 Pages: 339 - 351
Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports
Phuong Pham
Carmen Cheng
Monica A. Muñoz
Original Research Article 02 September 2021 Pages: 307 - 316
Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe
Steve Mayall
Randip Kahlon
Sophie W Shen
Original Research Article Open access 04 March 2021 Pages: 123 - 135
Building a Data Linkage Foundation for Mother–Child Pharmacoepidemiology Research
Christine C. Whitmore
R. Eric Hawley
Carlos G. Grijalva
Original Research Article 28 December 2020 Pages: 39 - 47
A Comprehensive Methodology to Systematically Identify Drug Hypersensitivity and Anaphylactic Reactions in Clinical Trial Databases
Hugo Xavier
Indira Hara
Claire Morgan
Original Research Article 25 September 2020 Pages: 335 - 345
Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil
Marcelo Vogler
Heloísa Ricci Conesa
Yannie Silveira Gonçalves
Leading Article Open access 15 September 2020 Pages: 327 - 334
Automation Opportunities in Pharmacovigilance: An Industry Survey
Rajesh Ghosh
Dieter Kempf
Sundeep Sethi
Original Research Article Open access 08 February 2020 Pages: 7 - 18

Drug Safety

Participating journal

Pharmaceutical Medicine

Articles

Statistical Signal Detection Algorithm in Safety Data: A Proprietary Method Compared to Industry Standard Methods

Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria

Why Oncology Global Safety Teams Should Develop the Safety Section of the Study’s Target Product Profile (TPP)

Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures

Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management

Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials

Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems

Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines

Correction to: The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities

Recognition of Coroners’ Concerns to Prevent Future Deaths from Medicines: A Systematic Review

The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities

A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials

Value and Implementation of the Aggregate Safety Assessment Plan

The Use of Artificial Intelligence in Pharmacovigilance: A Systematic Review of the Literature

Utilizing Deep Learning for Detecting Adverse Drug Events in Structured and Unstructured Regulatory Drug Data Sets

A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment

Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research

Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions

An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach

Dispositions and Causality Assessment in Pharmacovigilance: Proposing the Dx3 Approach for Assessing Causality with Small Data Sets

Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder

Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns

Digital Additional Risk Minimization Measures: An Exploratory Study Using Qualitative Feedback from Healthcare Professionals and Patients Across Six Countries

Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union

Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe

Building a Data Linkage Foundation for Mother–Child Pharmacoepidemiology Research

A Comprehensive Methodology to Systematically Identify Drug Hypersensitivity and Anaphylactic Reactions in Clinical Trial Databases

Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil

Automation Opportunities in Pharmacovigilance: An Industry Survey

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