CLS Program

From KATYAG@otsuka.oapi.com Tue Oct 1 16:14:16 1996 Subject: CLS Program Kyungsoo and others who have the experience with CLS program, can the program be used with more complex data than in the examples provided with the program? Specifically: 1. What if plasma concentrations spread all over the dosing interval, but for each particular individual observations are concentrated in a small range, say, one to two hours. May I expect reasonable estimates of AUC? If yes, how many break points to use, where ? 2. What if there are no observations at 0 or/and at the end of a dosing interval for steady state. Should I still have break points there? Is there another way to constrain the spline at these points? 3. If there is a positive answer to the previous question, then another complication: can the steady state requirement at times 0 and T be combined with the requirement of a decreasing tail at times >T ? I.e., if being at a steady state a patient skips the last dose and has a plasma measurement later. Is there a way to handle it? Thanks in advance. Katya Gibiansky Otsuka America Pharmaceuticals, Inc. 2440 Research Blvd, Rockville, MD 20850 USA E-mail: katyag@otsuka.oapi.com Phone: (301)-527-4911 Fax: (301)-212-8582