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• W1524705737 abstract "This chapter describes the different study types, key study designs and considerations for toxicity assessment of specific organ systems. It presents a general guide for comparative age categories between different animal species and humans with regard to central nervous system and reproductive organ development. Both the terms “pediatric” and “biopharmaceutical“ share a common element in that each term represents what can be extremely diverse “populations”. A few of the key considerations for biopharmaceuticals as they impact study design are: species selection/crossreactivity; immunogenicity of the biopharmaceutical; pharmacokinetics/toxicokinetics, distribution and elimination. The chapter also talks about the considerations needed in the testing designs for a number of specific target organs or systems. As the knowledge from juvenile animal studies grows, a better understanding of the clinical relevance of findings will be achieved." @default.
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• W1524705737 date "2013-07-31" @default.
• W1524705737 modified "2023-10-18" @default.
• W1524705737 title "Juvenile Animal Toxicity Assessments: Decision Strategies and Study Design" @default.
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• W1524705737 doi "https://doi.org/10.1002/9781118312087.ch19" @default.
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