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Therapeutic Drug Monitoring Data: A Concise Guide

4th edition., 2019

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Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership

Statistics in medicine, 2012-12, Vol.31 (30), p.4401-4415

2012

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Repairing the broken market for antibiotic innovation

Health Affairs, 2015-02, Vol.34 (2), p.277-285

2015

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Novel Statistical Tools for Monitoring the Safety of Marketed Drugs

Clinical pharmacology and therapeutics, 2007-08, Vol.82 (2), p.157-166

2007

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RSA and registries: the quest for phased introduction of new implants

Journal of bone and joint surgery. American volume, 2011-12, Vol.93 Suppl 3 (Supplement_3), p.62-65

2011

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Leveraging the entire cohort in drug safety monitoring: part 1 methods for sequential surveillance that use regression adjustment or weighting to control confounding in a multisite, rare event, distributed data setting

Journal of clinical epidemiology, 2019-08, Vol.112, p.77-86

2019

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The evolution of biotechnology and its impact on health care

Health Affairs, 2015-02, Vol.34 (2), p.210-219

2015

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Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

JAMA network open, 2024-05, Vol.7 (5), p.e249233-e249233

2024

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Preventing Medical Device Recalls

Raheja, Dev

1, 2014

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Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children

BMC medical research methodology, 2018-12, Vol.18 (1), p.175-10, Article 175

2018

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Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data

Arthritis research & therapy, 2019-05, Vol.21 (1), p.111-11, Article 111

2019

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Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators

Pharmacoepidemiology and drug safety, 2018-08, Vol.27 (8), p.848-856

2018

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Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

JAMA : the journal of the American Medical Association, 2017-08, Vol.318 (7), p.626

2017

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Current challenges for clinical trials of cardiovascular medical devices

International journal of cardiology, 2014-07, Vol.175 (1), p.30-37

2014

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Pharmacovigilance in Europe and North America: Divergent approaches

Social science & medicine (1982), 2012-07, Vol.75 (1), p.165-170

2012

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Case studies on forecasting for innovative technologies: frequent revisions improve accuracy

Health Affairs, 2015-02, Vol.34 (2), p.311-318

2015

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Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms

JAMA internal medicine, 2021-10, Vol.181 (10), p.1275

2021

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The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers

BMC research notes, 2015-11, Vol.8 (633), p.634-634, Article 634

2015

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Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives

Pharmacoepidemiology and drug safety, 2013-09, Vol.22 (9), p.1004-1012

2013

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Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation: A Prospective Study Using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)

Journal of the American College of Cardiology, 2011-05, Vol.57 (19), p.1890-1898

2011

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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Clinical pharmacology and therapeutics, 2019-07, Vol.106 (1), p.103-115

2019

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Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance

Pharmacoepidemiology and drug safety, 2019-09, Vol.28 (9), p.1211-1221

2019

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A decade of change

Nature reviews. Drug discovery, 2012-01, Vol.11 (1), p.17-18

Arrowsmith, John

2012

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Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real‐World Data From Electronic Health Records

Clinical pharmacology and therapeutics, 2020-04, Vol.107 (4), p.934-943

2020

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Therapeutic Drug Monitoring Data: A Concise Guide

Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership

Repairing the broken market for antibiotic innovation

Novel Statistical Tools for Monitoring the Safety of Marketed Drugs

RSA and registries: the quest for phased introduction of new implants

Leveraging the entire cohort in drug safety monitoring: part 1 methods for sequential surveillance that use regression adjustment or weighting to control confounding in a multisite, rare event, distributed data setting

The evolution of biotechnology and its impact on health care

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

Preventing Medical Device Recalls

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children

Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

Current challenges for clinical trials of cardiovascular medical devices

Pharmacovigilance in Europe and North America: Divergent approaches

Case studies on forecasting for innovative technologies: frequent revisions improve accuracy

Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms

The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers

Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives

The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation: A Prospective Study Using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)

A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance

A decade of change

Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real‐World Data From Electronic Health Records

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