Regimen Dependency

Other investigators have also described regimen dependency for IL-12 given IV (91) and SC (92). For example, Motzer and colleagues (92) treated patients 

FIGURE 32.18 Regimen dependency of IL-12 pharmacokinetics and IFNy stimulating effects. In the left panel, IL-12 serum concentrations are compared in patients who received a subcutaneous dose of 1.0 g/mL IL-12 on day 1 of their therapy ( ) with levels obtained in other patients who received the same dose on day 15 of an escalating-dose scheme (A). In the right panel, the IFNy responses of these two patient groups are compared. (Reproduced with permission from Motzer RJ et al. Clin Cancer Res 1998 4 1183-91.) 

2004 report to the nation Improving health through human drugs. Rockville, MD FDA 2005. (Internet at http //www.fda.gov/cder/reports/rtn/ 2004/rtn2004.htm.) 

2004 survey. Medicines in development for biotechnology, 2004. Washington, D.C. PhRMA 2004. (Internet at http //www.phrma.org/ newmedicines / surveys. cfm newmedsr index=7 6.) 

Cote RJ, Morrissey DM, Houghtone AN, Beattie EJ, Oettgen HE, Old LJ. Generation of human monoclonal antibodies reactive with cellular antigens. Proc Natl Acad Sci USA 1983 80 202 30. 

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Usually, one has obtained an estimate for the elimination constant and the distribution volume Vp from a single intravenous injection. These pharmacokinetic parameters, together with the interval between administrations 0 and the single-dose D, then allow us to compute the steady-state peak and trough values. The criterion for an optimal dose regimen depends on the minimum therapeutic concentration (which must be exceeded by and on the maximum safe... 

The optimal dosage regimen for patients with renal insufficiency requires an individualized assessment (Table 77-2). The optimal regimen depends on an accurate characterization of the relationship between the drug s pharmacokinetic parameters and renal function and on an accurate assessment of the patient s residual renal function. 

Conduct other in vivo evaluations including, but not limited to, dosing regimen dependency route of administration and formulation dependency and spectrum of activity, disease status, crossresistance profile, combination therapy for synergy or antagonism, and special models. 

The regimen depends on the condition of the patient the doses quoted are for adults. Chloroquine resistance is now usual. 

Types of Dosing. Vaccines can be administered according lo a variety of dosing regimens, depending on tic vaccine type and the purpose of the injection ... 

Prophylaxis for infections with drug-resistant strains of P. falciparum or P. vivax. Note The choice of regimen depends on the local geographic profile of drug resistance and other factors see text). 

Slattery JT, KaUiom TF, McDonald GB, Lambert K, Buckner CD, Bensinger WI, Anasetti C, Appelbaum FR. Conditioning regimen-dependent disposition of cyclophosphamide and hy-drojQfcyclophosphamide in human marrow transplantation patients. J Clin Oncol (1996) 14, 1484-94. 

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