title: Requirements for valid alternative assays for testing of biological therapeutic agents.
abstract: Several novel toxin-derived biological therapeutic products are now available or under development. There is thus an increasing need to develop alternative assays for their efficacy testing, which currently still depends largely on in vivo methods. Scientific advances in the understanding of the mode of action of these substances has not only fuelled the pace of their development as therapeutic agents but has also provided the basis for improving upon conventional testing procedures.
authors.affiliation: Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.
authors.forename: D
authors.initials: D
authors.lastname: Sesardic
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D000992:Antitoxins / Q000032:analysis; D001427:Bacterial Toxins / Q000032:analysis; D001681:Biological Assay / Q000379:methods; D001688:Biological Products / Q000032:analysis* / Q000494:pharmacology; D002522:Chlorocebus aethiops; D006801:Humans; D066298:In Vitro Techniques; D009500:Neutralization Tests; D015203:Reproducibility of Results; D014709:Vero Cells
chemical_list: D000992:Antitoxins; D001427:Bacterial Toxins; D001688:Biological Products