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.

J Biol Stand. 1989 Jul;17(3):203-12. doi: 10.1016/0092-1157(89)90012-7.

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