Silva-Lizama E

Language: Spanish
References: 5
Page: 143-144
PDF size: 99.58 Kb.

Text Extraction

No abstract

REFERENCES

1. Bergamo N, Traspalacios V, Marquez M, Perez S, Samaniego S, Vander E. Good clinical practices (GCP) in latin America: prospects for regional harmonization: a challenge for the Twenty –fi rst century. Drug Information J 2001;35:27-34.

2. Goihman Y M. Ethical aspects of the relationship of dermatology and industry: the independents Ethics Commitee. Int J Dermatol 2004;43:74-6.

3. Lissok Alan. FDA Audits of clinicalstujdies: polity and procedure. J Clin Pharmacol 1990;30:296-302

4. Fitzgerald DW, Marotte C, Verdier RI, et al. Comprehension during informed consent in a less.developed country. Lancet 2002;360:1301-2

5. U.S. Food and Drug administration, Information Sheets, Sponsor-investigator-IRB Interrelationship www.fda.gov/oc/ohrt/irbstoc4.html.