Matches in SemOpenAlex for { <https://semopenalex.org/work/W2017379966> ?p ?o ?g. }
Showing items 1 to 78 of
78
with 100 items per page.
- W2017379966 endingPage "500" @default.
- W2017379966 startingPage "494" @default.
- W2017379966 abstract "The ICH S6 guidance was developed to describe a rational science-based flexible approach to the preclinical evaluation for biotechnology-derived pharmaceutical products. It also suggested that some of the principles described may be suitable for plasma-derived therapeutics. Some of the specific concerns unique to protein-based therapeutics include complexity in structure and potential immunogenicity. S6 has been interpreted by some industry and regulatory authorities, often due to lack of experience with these types of products, as encouraging a broader or more conventional toxicology program similar to that normally conducted for small molecules. The guidance does encourage important and necessary preclinical evaluations but also recognizes the limitations of studies in non-relevant animal species because they are without pharmacological interaction with the biologic. In addition, studies of human proteins are often limited in useful chronic, reproductive and carcinogenic toxicity evaluations by the immunological response in animals. Thus the safety evaluation of biopharmaceuticals and plasma derivatives in animals has limitations that cannot be adequately addressed by the use of testing paradigms used for small molecule pharmaceuticals. S6 focuses evaluations on well-designed studies in relevant species for reasonable time periods to make the best use of available resources and enable clinical trials." @default.
- W2017379966 created "2016-06-24" @default.
- W2017379966 creator A5019599889 @default.
- W2017379966 creator A5072969331 @default.
- W2017379966 date "2010-07-01" @default.
- W2017379966 modified "2023-10-18" @default.
- W2017379966 title "The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products" @default.
- W2017379966 cites W106465137 @default.
- W2017379966 cites W1516645853 @default.
- W2017379966 cites W1541396918 @default.
- W2017379966 cites W1579104679 @default.
- W2017379966 cites W1925825565 @default.
- W2017379966 cites W1938851020 @default.
- W2017379966 cites W1954413372 @default.
- W2017379966 cites W2012750516 @default.
- W2017379966 cites W2021059438 @default.
- W2017379966 cites W2034773742 @default.
- W2017379966 cites W2065781967 @default.
- W2017379966 cites W2496668831 @default.
- W2017379966 cites W35246234 @default.
- W2017379966 cites W2293142800 @default.
- W2017379966 doi "https://doi.org/10.1016/j.biologicals.2010.03.001" @default.
- W2017379966 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/20359910" @default.
- W2017379966 hasPublicationYear "2010" @default.
- W2017379966 type Work @default.
- W2017379966 sameAs 2017379966 @default.
- W2017379966 citedByCount "2" @default.
- W2017379966 countsByYear W20173799662012 @default.
- W2017379966 countsByYear W20173799662013 @default.
- W2017379966 crossrefType "journal-article" @default.
- W2017379966 hasAuthorship W2017379966A5019599889 @default.
- W2017379966 hasAuthorship W2017379966A5072969331 @default.
- W2017379966 hasConcept C112930515 @default.
- W2017379966 hasConcept C127413603 @default.
- W2017379966 hasConcept C150903083 @default.
- W2017379966 hasConcept C183696295 @default.
- W2017379966 hasConcept C203014093 @default.
- W2017379966 hasConcept C2780868878 @default.
- W2017379966 hasConcept C41008148 @default.
- W2017379966 hasConcept C70721500 @default.
- W2017379966 hasConcept C71924100 @default.
- W2017379966 hasConcept C86803240 @default.
- W2017379966 hasConcept C8891405 @default.
- W2017379966 hasConcept C98274493 @default.
- W2017379966 hasConceptScore W2017379966C112930515 @default.
- W2017379966 hasConceptScore W2017379966C127413603 @default.
- W2017379966 hasConceptScore W2017379966C150903083 @default.
- W2017379966 hasConceptScore W2017379966C183696295 @default.
- W2017379966 hasConceptScore W2017379966C203014093 @default.
- W2017379966 hasConceptScore W2017379966C2780868878 @default.
- W2017379966 hasConceptScore W2017379966C41008148 @default.
- W2017379966 hasConceptScore W2017379966C70721500 @default.
- W2017379966 hasConceptScore W2017379966C71924100 @default.
- W2017379966 hasConceptScore W2017379966C86803240 @default.
- W2017379966 hasConceptScore W2017379966C8891405 @default.
- W2017379966 hasConceptScore W2017379966C98274493 @default.
- W2017379966 hasIssue "4" @default.
- W2017379966 hasLocation W20173799661 @default.
- W2017379966 hasLocation W20173799662 @default.
- W2017379966 hasOpenAccess W2017379966 @default.
- W2017379966 hasPrimaryLocation W20173799661 @default.
- W2017379966 hasRelatedWork W1508934482 @default.
- W2017379966 hasRelatedWork W2004499962 @default.
- W2017379966 hasRelatedWork W2019183242 @default.
- W2017379966 hasRelatedWork W2467048652 @default.
- W2017379966 hasRelatedWork W2748952813 @default.
- W2017379966 hasRelatedWork W2899084033 @default.
- W2017379966 hasRelatedWork W2938592129 @default.
- W2017379966 hasRelatedWork W3048418704 @default.
- W2017379966 hasRelatedWork W3091991776 @default.
- W2017379966 hasRelatedWork W913107711 @default.
- W2017379966 hasVolume "38" @default.
- W2017379966 isParatext "false" @default.
- W2017379966 isRetracted "false" @default.
- W2017379966 magId "2017379966" @default.
- W2017379966 workType "article" @default.