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Literature DB >> 29670312

Pharmacovigilance and expedited drug approvals.

Matthew Linger¹, Jennifer Martin².

Abstract

Keywords: Therapeutic Goods Administration; adverse effects; drug regulation; postmarket surveillance

Year: 2018 PMID： 29670312 PMCID： PMC5895470 DOI： 10.18773/austprescr.2018.010

Source DB: PubMed Journal: Aust Prescr ISSN： 0312-8008

× No keyword cloud information.

7 in total

1. Diuretics, ACE inhibitors and NSAIDs--the triple whammy.

Authors: M C Thomas
Journal: Med J Aust Date: 2000-02-21 Impact factor: 7.738

2. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.

Authors: Joel Lexchin
Journal: Br J Clin Pharmacol Date: 2015-05 Impact factor: 4.335

3. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.

Authors: Thomas J Moore; Curt D Furberg; Donald R Mattison; Michael R Cohen
Journal: Pharmacoepidemiol Drug Saf Date: 2016-02-10 Impact factor: 2.890

Review 4. Effect of different antilipidemic agents and diets on mortality: a systematic review.

Authors: Marco Studer; Matthias Briel; Bernd Leimenstoll; Tracy R Glass; Heiner C Bucher
Journal: Arch Intern Med Date: 2005-04-11

5. The hazards of rapid approval of new drugs.

Authors: Jennifer Martin; Gillian Shenfield
Journal: Aust Prescr Date: 2016-02-01

6. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Authors: Marc S Sabatine; Robert P Giugliano; Anthony C Keech; Narimon Honarpour; Stephen D Wiviott; Sabina A Murphy; Julia F Kuder; Huei Wang; Thomas Liu; Scott M Wasserman; Peter S Sever; Terje R Pedersen
Journal: N Engl J Med Date: 2017-03-17 Impact factor: 91.245

Review 7. Under-reporting of adverse drug reactions : a systematic review.

Authors: Lorna Hazell; Saad A W Shakir
Journal: Drug Saf Date: 2006 Impact factor: 5.228

7 in total

4 in total

Pharmacovigilance and expedited drug approvals.

1. Diuretics, ACE inhibitors and NSAIDs--the triple whammy.

2. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.

3. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.

Review 4. Effect of different antilipidemic agents and diets on mortality: a systematic review.

5. The hazards of rapid approval of new drugs.

6. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Review 7. Under-reporting of adverse drug reactions : a systematic review.

1. A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding.

2. Automated adverse drug reaction detection.

3. Medication Risk Management.

4. Reporting adverse drug events to the Therapeutic Goods Administration.