Preclinical assessments of european union marketing authorisation applications for immunomodulatory biopharmaceuticals.
A review of preclinical assessment reports on immunomodulatory biopharmaceuticals submitted to the European Agency for Evaluation of Medicinal Products from 1995 to the middle of 1999 was conducted. Questions regarding the rationale for the preclinical development programmes were often put to the applicants. Effects mediated via changes of the immune function, including risks of reproductive toxicity and tumorigenicity, were of particular concern. This review indicates the need to further develop methods for safety testing of immunomodulatory biopharmaceuticals.
Medical Products Agency, Uppsala, Sweden.
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D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000494:pharmacology* / Q000633:toxicity; D000818:Animals; D001702:Biopharmaceutics; D018795:Device Approval; D004353:Drug Evaluation, Preclinical; D005062:European Union; D006801:Humans
D000276:Adjuvants, Immunologic