We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.
- Authors
Snodin, David J; Ryle, Peter R
- Abstract
Biotechnology-derived pharmaceuticals are a well established and growing part of the therapeutic armamentarium. Beginning with recombinant versions of products such as insulin that were previously manufactured by extraction from animal and human sources, licensed biotechnology drugs and those in development now span an ever-increasing range of product types and therapeutic categories. As a consequence of this diversity, both general and product class-specific scientific guidelines have been developed on a regional (e.g. EU/US) or international (e.g. ICH - International Conference on Harmonization) basis. The current portfolio of nonclinical guidelines, particularly ICH S6, emphasizes flexibility and adaptability to the specific circumstances of the individual biotechnology product and its intended indication, taking into account factors not generally applicable to small-molecule drugs, such as pharmacodynamic responsiveness of safety and efficacy models, species specificity, and antibody formation. Guidelines developed principally with small-molecule drugs in mind may, nevertheless, have some applicability to biotechnology drugs on issues such as safety pharmacology, as well as on regulatory, procedural and dossier submission requirements. Scientific guidelines, such as those providing nonclinical guidance, are just one, albeit important, component of an increasingly complex legal/scientific environment in drug development.
- Publication
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2006, Vol 20, Issue 1, p25
- ISSN
1173-8804
- Publication type
Journal Article
- DOI
10.2165/00063030-200620010-00003