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Evaluation of Oncology Drugs at the European Medicines Agency and US Food and Drug Administration: When Differences Have an Impact on Clinical Practice

Journal of clinical oncology, 2011-06, Vol.29 (16), p.2266-2272

2011

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Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

Drug safety, 2013-08, Vol.36 (8), p.617-625

2013

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Pharmacovigilance of Biopharmaceuticals: Challenges Remain

Drug safety, 2009-10, Vol.32 (10), p.811-817

2009

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Is aspirin useful in patients on lithium? A pharmacoepidemiological study related to bipolar disorder

Prostaglandins, leukotrienes and essential fatty acids, 2010-01, Vol.82 (1), p.9-14

2010

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Risk of Aplastic Anemia in Patients Using Antiepileptic Drugs

Epilepsia (Copenhagen), 2006-07, Vol.47 (7), p.1232-1236

2006

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In‐hospital cardiac arrest is associated with use of non‐antiarrhythmic QTc‐prolonging drugs

British journal of clinical pharmacology, 2007-02, Vol.63 (2), p.216-223

2007

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The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

European journal of clinical pharmacology, 2013-02, Vol.69 (2), p.217-226

2013

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Mapping the Safety Profile of Biologicals: A Disproportionality Analysis Using the WHO Adverse Drug Reaction Database, VigiBase

Drug safety, 2010-10, Vol.33 (10), p.865-878

2010

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Predictors of orphan drug approval in the European Union

European journal of clinical pharmacology, 2008-05, Vol.64 (5), p.545-552

2008

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Determinants for successful marketing authorisation of orphan medicinal products in the EU

Drug discovery today, 2012-04, Vol.17 (7-8), p.352-358

2012

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Off-label use of medicines in children: can available evidence avoid useless paediatric trials?: The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease

European journal of clinical pharmacology, 2009-02, Vol.65 (2), p.209-216

2009

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Safety-Related Regulatory Actions for Orphan Drugs in the US and EU: A Cohort Study

Drug safety, 2010-02, Vol.33 (2), p.127-137

2010

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Information for Adequate Prescribing to Older Patients: An Evaluation of the Product Information of 53 Recently Approved Medicines

Drugs & aging, 2013-04, Vol.30 (4), p.255-262

2013

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Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval

Drug safety, 2009-01, Vol.32 (12), p.1175-1187

2009

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A Cohort Study Exploring Determinants of Safety-Related Regulatory Actions for Biopharmaceuticals

Drug safety, 2012-05, Vol.35 (5), p.417-427

2012

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Therapeutic indications in oncology: Emerging features and regulatory dynamics

European journal of cancer (1990), 2010-02, Vol.46 (3), p.471-475

2010

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Incidence of Adverse Events Among Healthcare Workers Following H1N1 Mass Immunization in Ghana: A Prospective Study

Drug safety, 2013-04, Vol.36 (4), p.259-266

2013

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Randomized Controlled Trials of COX-2 Inhibitors: An Analysis of Doses Used and Trends Over Time to Investigate Implications for Comparative Safety

Drug safety, 2011-09, Vol.34 (9), p.783-792

2011

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Evaluation of the clinical value of pharmacists’ modifications of prescription errors

British journal of clinical pharmacology, 2004-11, Vol.58 (5), p.503-511

2004

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Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

British journal of clinical pharmacology, 2007-02, Vol.63 (2), p.159-162

2007

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Reasons for and Time to Discontinuation of Rimonabant Therapy: A Modified Prescription-Event Monitoring Study

Drug safety, 2012-12, Vol.35 (12), p.1147-1158

2012

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Angiotensin-converting enzyme inhibitor use and protection against pneumonia in patients with diabetes

Journal of hypertension, 2007, Vol.25 (1), p.235-239

2007

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Drug-Related Nephrotoxic and Ototoxic Reactions: A Link through a Predictive Mechanistic Commonality

Drug safety, 2008-01, Vol.31 (10), p.877-884

2008

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Incidence and determinants of long-term use of antidepressants

European journal of clinical pharmacology, 2004-03, Vol.60 (1), p.57-61

2004

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Orphan drug development across Europe: bottlenecks and opportunities

Drug discovery today, 2008-08, Vol.13 (15), p.670-676

2008

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Evaluation of Oncology Drugs at the European Medicines Agency and US Food and Drug Administration: When Differences Have an Impact on Clinical Practice

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

Pharmacovigilance of Biopharmaceuticals: Challenges Remain

Is aspirin useful in patients on lithium? A pharmacoepidemiological study related to bipolar disorder

Risk of Aplastic Anemia in Patients Using Antiepileptic Drugs

In‐hospital cardiac arrest is associated with use of non‐antiarrhythmic QTc‐prolonging drugs

The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

Mapping the Safety Profile of Biologicals: A Disproportionality Analysis Using the WHO Adverse Drug Reaction Database, VigiBase

Predictors of orphan drug approval in the European Union

Determinants for successful marketing authorisation of orphan medicinal products in the EU

Off-label use of medicines in children: can available evidence avoid useless paediatric trials?: The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease

Safety-Related Regulatory Actions for Orphan Drugs in the US and EU: A Cohort Study

Information for Adequate Prescribing to Older Patients: An Evaluation of the Product Information of 53 Recently Approved Medicines

Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval

A Cohort Study Exploring Determinants of Safety-Related Regulatory Actions for Biopharmaceuticals

Therapeutic indications in oncology: Emerging features and regulatory dynamics

Incidence of Adverse Events Among Healthcare Workers Following H1N1 Mass Immunization in Ghana: A Prospective Study

Randomized Controlled Trials of COX-2 Inhibitors: An Analysis of Doses Used and Trends Over Time to Investigate Implications for Comparative Safety

Evaluation of the clinical value of pharmacists’ modifications of prescription errors

Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

Reasons for and Time to Discontinuation of Rimonabant Therapy: A Modified Prescription-Event Monitoring Study

Angiotensin-converting enzyme inhibitor use and protection against pneumonia in patients with diabetes

Drug-Related Nephrotoxic and Ototoxic Reactions: A Link through a Predictive Mechanistic Commonality

Incidence and determinants of long-term use of antidepressants

Orphan drug development across Europe: bottlenecks and opportunities

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