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- W1986852088 endingPage "73" @default.
- W1986852088 startingPage "73" @default.
- W1986852088 abstract "Significant progress has been made in understanding pharmacokinetics (PK), pharmacodynamics (PD), as well as toxicity profiles of therapeutic proteins in animals and humans, which have been in commercial development for more than three decades. However, in the PK arena, many fundamental questions remain to be resolved. Investigative and bioanalytical tools need to be established to improve the translation of PK data from animals to humans, and from in vitro assays to in vivo readouts, which would ultimately lead to a higher success rate in drug development. In toxicology, it is known, in general, what studies are needed to safely develop therapeutic proteins, and what studies do not provide relevant information. One of the major complicating factors in nonclinical and clinical programs for therapeutic proteins is the impact of immunogenicity. In this review, we will highlight the emerging science and technology, as well as the challenges around the pharmacokinetic- and safety-related issues in drug development of mAbs and other therapeutic proteins." @default.
- W1986852088 created "2016-06-24" @default.
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- W1986852088 creator A5042055893 @default.
- W1986852088 creator A5091773218 @default.
- W1986852088 date "2012-01-01" @default.
- W1986852088 modified "2023-10-16" @default.
- W1986852088 title "Pharmacokinetics and toxicology of therapeutic proteins: Advances and challenges" @default.
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