Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals. Export

@article{citeulike:3380811, 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.}, author = {Snodin, D. J. and Ryle, P. R.}, citeulike-article-id = {3380811}, citeulike-linkout-0 = {http://view.ncbi.nlm.nih.gov/pubmed/16573349}, citeulike-linkout-1 = {http://www.hubmed.org/display.cgi?uids=16573349}, issn = {1173-8804}, journal = {BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy}, keywords = {biologics, nonclinical, regulatory}, number = {1}, pages = {25--52}, posted-at = {2008-10-06 23:46:58}, priority = {2}, title = {Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/16573349}, volume = {20}, year = {2006} }

TY - JOUR ID - citeulike:3380811 L3 - citeulike-article-id:3380811 N2 - 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. IS - 1 JF - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy SN - 1173-8804 EP - 52 TI - Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals. VL - 20 SP - 25 KW - biologics KW - nonclinical KW - regulatory AU - Snodin, DJ AU - Ryle, PR PY - 2006/// UR - http://view.ncbi.nlm.nih.gov/pubmed/16573349 ER -