Citation
R. Bass et al., Safety of biotechnological products, PHARM TOX, 86, 2000, pp. 27-29
Categorie Soggetti
Pharmacology & Toxicology
Journal title
PHARMACOLOGY & TOXICOLOGY
ISSN journal
09019928
→ ACNP
Volume
86
Year of publication
2000
Supplement
1
Pages
27 - 29
Database
ISI
SICI code
0901-9928(2000)86:<27:SOBP>2.0.ZU;2-B
Abstract
The safety of biotechnological products used for medicinal products is addr
essed by EU council directives. The general principles and the regulatory f
ramework for the handling of new drug applications within this areas are de
scribed both with respect to benefit/risk evaluation, quality assessment, p
reclinical safety and efficacy testing.