Monitoring for Adverse Events Post Marketing Approval of Drugs

Karl E. Peace; Macaulay Okwuokenye

Monitoring for Adverse Events Post Marketing Approval of Drugs

Karl E. Peace, Macaulay Okwuokenye

Biostatistics, Epidemiology, & Environmental Health Sciences

Georgia Southern University

Research output: Contribution to journal › Article › peer-review

Abstract

This brief communication provides information to those developing monitoring plans for serious adverse events (SAE’s) following regulatory approval of a new drug. In addition, we (1) illustrate how many patients would need to be treated in order to have high confidence of seeing at least 1 pre-specified SAE, (2) show that absence of proof of a SAE is not proof of absence of that SAE, and (3) identify statistical methodology that could be used for formal statistical monitoring of SAE’s.

Original language	American English
Journal	International Journal of Allergy Medications
Volume	1
State	Published - Nov 15 2015

Keywords

Drug approval
FDA
SAE's
Serious adverse events
US Food and Drug Administration

DC Disciplines

Biostatistics
Community Health
Public Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

Monitoring for Adverse Events Post Marketing Approval of DrugsFinal published version, 348 KBLicense: Unspecified

http://clinmedjournals.org/articles/ijam/international-journal-of-allergy-medications-ijam-1-010.pdf

Cite this

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title = "Monitoring for Adverse Events Post Marketing Approval of Drugs",

abstract = " This brief communication provides information to those developing monitoring plans for serious adverse events (SAE{\textquoteright}s) following regulatory approval of a new drug. In addition, we (1) illustrate how many patients would need to be treated in order to have high confidence of seeing at least 1 pre-specified SAE, (2) show that absence of proof of a SAE is not proof of absence of that SAE, and (3) identify statistical methodology that could be used for formal statistical monitoring of SAE{\textquoteright}s.",

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AU - Okwuokenye, Macaulay

PY - 2015/11/15

Y1 - 2015/11/15

N2 - This brief communication provides information to those developing monitoring plans for serious adverse events (SAE’s) following regulatory approval of a new drug. In addition, we (1) illustrate how many patients would need to be treated in order to have high confidence of seeing at least 1 pre-specified SAE, (2) show that absence of proof of a SAE is not proof of absence of that SAE, and (3) identify statistical methodology that could be used for formal statistical monitoring of SAE’s.

AB - This brief communication provides information to those developing monitoring plans for serious adverse events (SAE’s) following regulatory approval of a new drug. In addition, we (1) illustrate how many patients would need to be treated in order to have high confidence of seeing at least 1 pre-specified SAE, (2) show that absence of proof of a SAE is not proof of absence of that SAE, and (3) identify statistical methodology that could be used for formal statistical monitoring of SAE’s.

KW - Drug approval

KW - FDA

KW - SAE's

KW - Serious adverse events

KW - US Food and Drug Administration

UR - https://digitalcommons.georgiasouthern.edu/biostat-facpubs/118

M3 - Article

VL - 1

JO - International Journal of Allergy Medications

JF - International Journal of Allergy Medications

ER -

Monitoring for Adverse Events Post Marketing Approval of Drugs

Abstract

Keywords

DC Disciplines

UN SDGs

Access to Document

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Cite this