Notes to applicants for marketing authorizations on the pre-clinical biological safety testing of medicinal products derived from biotechnology (and comparable products derived from chemical synthesis). Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety of Medicines.
D000818:Animals; D000911:Antibodies, Monoclonal / Q000633:toxicity; D001685:Biological Factors / Q000633:toxicity; D001688:Biological Products / Q000493:pharmacokinetics / Q000494:pharmacology / Q000633:toxicity*; D001709:Biotechnology; D001798:Blood Proteins / Q000633:toxicity; D015197:Carcinogenicity Tests; D016207:Cytokines; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D006728:Hormones / Q000633:toxicity; D009152:Mutagenicity Tests; D012098:Reproduction / Q000187:drug effects; D013723:Teratogens; D014612:Vaccines / Q000633:toxicity
D000911:Antibodies, Monoclonal; D001685:Biological Factors; D001688:Biological Products; D001798:Blood Proteins; D016207:Cytokines; D006728:Hormones; D013723:Teratogens; D014612:Vaccines