Safety issues specific to clinical development of protein therapeutics.
Haller
C A
CA
Department of Global Regulatory Affairs and Safety, Amgen Inc., South San Francisco, California, USA. challer@amgen.com
Cosenza
M E
ME
Sullivan
J T
JT
D001688:Biological Products / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011506:Proteins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends
D001688:Biological Products; D011506:Proteins