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A Comprehensive Guide to Toxicology in Preclinical Drug by Ali S. Faqi (Auth.)

By Ali S. Faqi (Auth.)

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In the beginning of this chapter, Eq. 3) was used to describe the elimination of compound from a beaker with a clearance ‘filter’. 27) Another way to write this equation (relating it to plasma concentration) is as follows: CL ¼ ðD mass=D timeÞ=ðCp ðaverageÞÞ Rearranging Eq. 28) gives Eqs. 30). , D time or Dt. From Eq. 26), massi represents a mass of compound eliminated during a small time segment, Dti . Therefore, Eq. 31) The term Cpi(average) is the average concentration during a short span of time, Dti.

Generally not antigenic unless reactive intermediates bind to protein (hapten hypothesis; rare). Idiosyncratic toxicity can be particularly challenging for small molecules. Can potentially be antigenic with MW >10 kDa. Extent of antigenicity can vary with site of injection (SC > IM > IV). Generally one bioanalytical method for preclinical studies and similar validated methods for GLP toxicology and human PK. LC-MS/MS assays are very common. , for PK/ TK studies. Validated assays required for GLP toxicology studies as well as clinical studies.

Biologics do not absorb across cell membranes readily. When the MW is >15e20 kDa, the lymphatic system becomes an increasingly important mechanism to reach circulation after extravascular administration. These molecules are subject to proteolysis at the site of injection as well as during interstitial and lymphatic transit. Wide range of clearance values and half lives are possible. Clearance frequently occurs in the liver and kidneys. Clearances are generally low, and half lives are generally long for monoclonal antibodies and fusion proteins.

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