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The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs

Pharmacoepidemiology and drug safety, 2024-01, Vol.33 (1), p.e5719-n/a

2024

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RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes

The New England journal of medicine, 2024-03, Vol.390 (11), p.1009

2024

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Thomas Breuer and colleagues at GlaxoSmithKline respond to Peter Doshi

BMJ (Online), 2018-10, Vol.363, p.k4116

2018

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Review of the initial post-marketing safety surveillance for the recombinant zoster vaccine

Vaccine, 2020-04, Vol.38 (18), p.3489-3500

2020

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Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

BMC public health, 2022-08, Vol.22 (1), p.1-1568, Article 1568

2022

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Results on exposure during pregnancy from a pregnancy registry for AS04-HPV-16/18 vaccine

Vaccine, 2017-09, Vol.35 (40), p.5325-5330

2017

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Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: A 10-day, phase III, randomized, double-blind, active- and placebo-controlled study

Clinical therapeutics, 2009-02, Vol.31 (2), p.260-271

2009

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Safety of medicines and vaccines – building next generation capability

Trends in pharmacological sciences (Regular ed.), 2021-12, Vol.42 (12), p.1051-1063

2021

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Trustworthy AI for safe medicines

Nature reviews. Drug discovery, 2023-10, Vol.22 (10), p.855-856

2023

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Artificial intelligence and pharmacovigilance: What is happening, what could happen and what should happen?

Health policy and technology, 2023-06, Vol.12 (2), p.100743, Article 100743

2023

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An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine

Drug safety, 2021-12, Vol.44 (12), p.1341-1353

2021

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Investigating Reports of Complex Regional Pain Syndrome: An Analysis of HPV-16/18-Adjuvanted Vaccine Post-Licensure Data

EBioMedicine, 2015-09, Vol.2 (9), p.1114-1121

2015

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Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

Drug safety, 2020-12, Vol.43 (12), p.1223-1234

2020

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Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Drug safety, 2020-06, Vol.43 (6), p.583-593

2020

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Tapentadol immediate release: a new treatment option for acute pain management

Journal of Pain Research, 2010-02, Vol.3 (default), p.1-9

2010

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A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain

Current medical research and opinion, 2009-06, Vol.25 (6), p.1551-1561

2009

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Signal management in pharmacovigilance and human risk assessment of CpG 7909, integrating embryo-fetal and post-natal developmental toxicity studies in rats and rabbits

Reproductive toxicology (Elmsford, N.Y.), 2018-01, Vol.75, p.110-120

2018

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The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

Current medical research and opinion, 2008-11, Vol.24 (11), p.3185-3196

2008

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Antinociceptive effects of systemic lidocaine: Involvement of the spinal glycinergic system

European journal of pharmacology, 2009-06, Vol.613 (1), p.68-73

2009

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The spinal antinociceptive effect of nocistatin in neuropathic rats is blocked by D-serine

Anesthesiology (Philadelphia), 2004-09, Vol.101 (3), p.753-758

2004

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Correction to: Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Drug safety, 2021-06, Vol.44 (6), p.723-723

2021

Volltextzugriff (PDF)

Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule

Drugs of today (Barcelona, Spain : 1998), 2009-07, Vol.45 (7), p.483

2009

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Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Human vaccines & immunotherapeutics, 2019-10, Vol.15 (10), p.2386-2398

2019

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Frequency response characteristics of sympathetic transmission to skin vascular smooth muscles in rats

American journal of physiology. Regulatory, integrative and comparative physiology, 1999-08, Vol.277 (2), p.591-R600

1999

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2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction

Open forum infectious diseases, 2019-10, Vol.6 (Supplement_2), p.S979-S980

2019

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The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs

RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes

Thomas Breuer and colleagues at GlaxoSmithKline respond to Peter Doshi

Review of the initial post-marketing safety surveillance for the recombinant zoster vaccine

Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

Results on exposure during pregnancy from a pregnancy registry for AS04-HPV-16/18 vaccine

Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: A 10-day, phase III, randomized, double-blind, active- and placebo-controlled study

Safety of medicines and vaccines – building next generation capability

Trustworthy AI for safe medicines

Artificial intelligence and pharmacovigilance: What is happening, what could happen and what should happen?

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine

Investigating Reports of Complex Regional Pain Syndrome: An Analysis of HPV-16/18-Adjuvanted Vaccine Post-Licensure Data

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Tapentadol immediate release: a new treatment option for acute pain management

A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain

Signal management in pharmacovigilance and human risk assessment of CpG 7909, integrating embryo-fetal and post-natal developmental toxicity studies in rats and rabbits

The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

Antinociceptive effects of systemic lidocaine: Involvement of the spinal glycinergic system

The spinal antinociceptive effect of nocistatin in neuropathic rats is blocked by D-serine

Correction to: Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Frequency response characteristics of sympathetic transmission to skin vascular smooth muscles in rats

2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction

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