Symposium report--development of safe protein therapeutics: pre-clinical, clinical and regulatory issues.
The key elements of the symposium comprise the fact that for biosimilars--as opposed to generic small molecules--apart from comparable bioavailability also efficacy and safety data are required by registration authorities. Moreover, the importance of transgenic animals in efficacy and safety testing was treated as well as the different forms of immunotoxicity of biopharmaceuticals. Transgenic animals can also be used for the detection of aggregates of a biopharmaceutical. Finally, referral was made to the post-cytokine storm-incident (TGN1412)-developed first-in-human guideline, in which is prescribed that future clinical trials with biopharmaceuticals should start with a low dose, the MABEL.
Hospital Pharmacist Quality Assurance, Leiden University Medical Center, Clinical Pharmacy and Toxicology, P.O. Box 9600, 2300 RC Leiden, Netherlands. a.r.wafelman@lumc.nl
Amon R
AR
Wafelman
D000818:Animals; D030801:Animals, Genetically Modified; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical; D033161:Government Regulation; D006801:Humans; D023421:Models, Animal; D017410:Practice Guidelines as Topic; D011506:Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods; D016896:Treatment Outcome
D011506:Proteins