adverse drug experience Recently Published Documents

Periodic Adverse Drug Experience Reports, and Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports

Cobert's Manual of Drug Safety and Pharmacovigilance ◽

10.1142/9789813278851_0026 ◽

2019 ◽

pp. 239-246

Keyword(s):

Risk Evaluation ◽

Drug Experience ◽

Adverse Drug Experience ◽

Periodic Safety

Authoring a periodic adverse drug experience report…here's what you need to know!

Perspectives in Clinical Research ◽

10.4103/picr.picr_126_18 ◽

2019 ◽

Vol 10 (2) ◽

pp. 95

Author(s):

TejashreeN Kulkarni ◽

NiranjanG Kulkarni

Keyword(s):

Experience Report ◽

Drug Experience ◽

Digital gangrene induced by inadvertent intra-arterial cocktail injection of anesthetic agents such as pentazocine, promethazine, and atropine: A serious adverse drug experience

Indian Journal of Pharmacology ◽

10.4103/ijp.ijp_131_18 ◽

2018 ◽

Vol 50 (6) ◽

pp. 354 ◽

Cited By ~ 1

Author(s):

VishalR Tandon ◽

SoniaShinde Mahajan ◽

Rajat Sarin ◽

Roshi ◽

AkhilKumar Gupta ◽

...

Keyword(s):

Drug Experience ◽

Anesthetic Agents ◽

adverse drug experience (ADE)

Dictionary of Pharmaceutical Medicine ◽

10.1007/978-3-211-89836-9_33 ◽

2009 ◽

pp. 3-3

Author(s):

Gerhard Nahler

Keyword(s):

Drug Experience ◽

Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA

Pharmacoepidemiology and Drug Safety ◽

10.1002/(sici)1099-1557(199601)5:1<1::aid-pds203>3.0.co;2-t ◽

1996 ◽

Vol 5 (1) ◽

pp. 1-7 ◽

Cited By ~ 14

Author(s):

Syed Rizwanuddin Ahmad ◽

Joel P. Freiman ◽

David J. Graham ◽

Robert C. Nelson

Keyword(s):

Drug Experience ◽

Completeness of Adverse Drug Experience Reporting to the FDA: II. A Comparison of Manufacturer and Direct Reports on New Molecular Entities

10.1177/009286159402800140 ◽

1994 ◽

Vol 28 (1) ◽

pp. 315-321 ◽

Cited By ~ 1

Author(s):

Annie L. Britt ◽

Deanne E. Knapp

Keyword(s):

Drug Experience ◽

Direct Reports ◽

The Evaluation of Postmarketing Adverse Drug Experience Reports at FDA: Part I

10.1177/009286159302700433 ◽

1993 ◽

Vol 27 (4) ◽

pp. 1159-1165 ◽

Cited By ~ 2

Author(s):

Joyce M. Johnson ◽

L. Ann Tanner ◽

David Barash

Keyword(s):

Drug Experience ◽

Safety Signals from Adverse Drug Experience Reports at FDA: Part II

10.1177/009286159302700434 ◽

1993 ◽

Vol 27 (4) ◽

pp. 1167-1171

Author(s):

Joyce M. Johnson ◽

L. Ann Tanner ◽

David Barash

Keyword(s):

Drug Experience ◽

Adverse Drug Experience ◽

Safety Signals

Clinical Trial Adverse Drug Experience Reporting Requirements in the Major Countries and a Simplified Approach toward Meeting These Requirements

10.1177/009286159202600408 ◽

1992 ◽

Vol 26 (4) ◽

pp. 519-525

Author(s):

Max W. Talbott ◽

Ellen Kelso

Keyword(s):

Clinical Trial ◽

Drug Experience ◽

Simplified Approach ◽

Reporting Requirements ◽