Current guidelines for the preclinical safety assessment of therapeutic proteins.

Abstract:

:Guidelines concerning the preclinical safety assessment of therapeutic proteins are available, e.g. in the European Community (EC Notes for Guidance). Unlike rather rigidly prescribing test systems such as those known for chemical substances, it is agreed that for biotechnologically-produced products, testing may be quite different. Those guidelines which allow for a true case-by-case development have been considered the best; however, regulatory authorities are expected to disagree ex post with the approach chosen earlier. To allow for a scientific rationale, which includes the freedom to deviate from the expected norm, guidance must include an offer for discussion of requirements. This combination of recommendations (not requirements) with optional discussions has been the European approach. Although the American approach is known to be somewhat more case-by-case oriented, and the Japanese approach is known to be somewhat more strict, the outcome of drug development, i.e. the application of guidance, in the three regions has been strikingly similar. This underlines the importance of a pharmaceutical manufacturer and his ability to interpret the rules in the light of the product to be developed.

journal_name

Toxicol Lett

journal_title

Toxicology letters

authors

Bass R,Kleeberg U,Schröder H,Scheibner E

doi

10.1016/0378-4274(92)90206-y

keywords:

subject

Has Abstract

pub_date

1992-12-01 00:00:00

pages

339-47

eissn

0378-4274

issn

1879-3169

pii

0378-4274(92)90206-Y

journal_volume

64-65 Spec No

pub_type

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