Multi-dose pharmacokinetic studie

Garcia CA, Connelly B, Thomas E, et al. A phase 2 multi-dose pharmacokinetic study of MS1-1256F (squalamine lactate) for... 

Kinetic studies are important for interpreting the results of the toxicity studies. Pharmaco- and toxicokinetics should be evaluated in single- and, in some cases, multiple-dose studies. Multi-dose pharmacokinetic studies are important to assess accumulation between doses, the impact of antibody formation on systemic exposure and whether inducible clearance exists therefore, these studies should be done in relevant species - preferably in conjunction with the toxicity studies. Information on the disposition of interferons and interleukins, particularly the clearance rate and clearance organs, is desirable. 

The pharmacokinetics (PK) of the MAb in the test species should be measured for several reasons. First, PK in the test species will provide the basis for dosing frequency in multi-dose toxicity studies. Second, if the MAb is antigenic in the test species, an alteration in PK will probably obviate the need for long-term toxicity testing. Finally, once human PK data are available, crossspecies comparison will provide an important perspective on the relevance of the test species and any toxicities. 

Pharmacokinetics of HMR1964 (insulin glulisine) after subcutaneous injection of a single dose of 0.15 lU/kg in non-diabetic subjects with different degrees of renal function in an open, parallel group, single dose, multi center study. 

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