Literature DB >> 9297731

Good practice in the postmarketing surveillance of medicines.

R H Meyboom1.   

Abstract

In addition to Good Clinical Trial Practice for the study of experimental drugs, regulations are also needed for good practice in the assessment of medicines after approval (Good PMS Practice, GPP). GPP has to protect the interests of public health at large as well as those of individual patients, investigators and pharmaceutical companies. GPP may be the natural way to solve threatening conflicts between privacy legislation and the public interest.

Entities:  

Mesh：

Year:  1997        PMID： 9297731     DOI： 10.1023/a:1008610722972

Source DB:  PubMed          Journal:  Pharm World Sci        ISSN： 0928-1231


  9 in total

1.  Guidelines for Good Epidemiology Practices for drug, device, and vaccine research in the United States.

Authors:  E A Andrews; J Avorn; E A Bortnichak; R Chen; W S Dai; G S Dieck; S Edlavitch; J Freiman; A A Mitchell; R C Nelson; C I Neutel; A Stergachis; B L Strom; A M Walker
Journal:  Pharmacoepidemiol Drug Saf       Date:  1996-09       Impact factor: 2.890

2.  The use of confidential medical data and postmarketing surveillance: a survey of the opinion of patients.

Authors:  M E de Wit; A J Porsius; B H Stricker
Journal:  Pharmacoepidemiol Drug Saf       Date:  1996-09       Impact factor: 2.890

3.  Basic requirements for the use of terms for reporting adverse drug reactions (VIII): renal and urinary system disorders.

Authors: 
Journal:  Pharmacoepidemiol Drug Saf       Date:  1997-05       Impact factor: 2.890

4.  Quality criteria for early signals of possible adverse drug reactions.

Authors:  I R Edwards; M Lindquist; B E Wiholm; E Napke
Journal:  Lancet       Date:  1990-07-21       Impact factor: 79.321

5.  Speaking about pharmacovigilance.

Authors:  D McNamee
Journal:  Lancet       Date:  1996-10-05       Impact factor: 79.321

6.  Spontaneous reporting of adverse drug reactions. I: the data.

Authors:  M D Rawlins
Journal:  Br J Clin Pharmacol       Date:  1988-07       Impact factor: 4.335

7.  [Information and consent in health care; current developments].

Authors:  H D Roscam Abbing
Journal:  Ned Tijdschr Geneeskd       Date:  1994-12-17

Review 8.  Harmonisation in pharmacovigilance.

Authors:  I R Edwards; C Biriell
Journal:  Drug Saf       Date:  1994-02       Impact factor: 5.606

9.  Why the Safety Assessment of Marketed Medicines (SAMM) guidelines are needed.

Authors:  P C Waller; S M Wood; A M Breckenridge; M D Rawlins
Journal:  Br J Clin Pharmacol       Date:  1994-08       Impact factor: 4.335
  9 in total
  4 in total

1.  The role of the French community pharmacist in drug dispensing.

Authors:  G Chamba; G Bauguil; J Galiezot
Journal:  Pharm World Sci       Date:  1999-06

Review 2.  Pharmacovigilance in perspective.

Authors:  R H Meyboom; A C Egberts; F W Gribnau; Y A Hekster
Journal:  Drug Saf       Date:  1999-12       Impact factor: 5.606

3.  Causal or casual? The role of causality assessment in pharmacovigilance.

Authors:  R H Meyboom; Y A Hekster; A C Egberts; F W Gribnau; I R Edwards
Journal:  Drug Saf       Date:  1997-12       Impact factor: 5.606

4.  Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide: results of spontaneous reporting from a Northern Italian area.

Authors:  A Conforti; R Leone; U Moretti; F Mozzo; G Velo
Journal:  Drug Saf       Date:  2001       Impact factor: 5.606
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.