Clinical and Translational Pharmacology Considerations for Anti-infectives Approved Under the FDA Animal Rule

Temrikar, ZH; Golden, JE; Jonsson, CB; Meibohm, B

Meibohm, B (通讯作者),Univ Tennessee, Coll Pharm, Dept Pharmaceut Sci, Hlth Sci Ctr, 881 Madison Ave, Memphis, TN 38163 USA.

CLINICAL PHARMACOKINETICS, 2023; 62 (7): 943

Abstract

The US Food and Drug Administration's Animal Rule provides a pathway for approval of drugs and biologics aimed to treat serious or life-threatening co......

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