Re: Question for Non-Compartment Anaylsis

From: Nick Holford <n.holford@auckland.ac.nz> Subject: Re: Question for Non-Compartment Anaylsis Date: Sat, 13 Jan 2001 08:35:41 +1300 Jeff Wald wrote: > Wei - Selection of software should first start with a definition of what > your objectives are in the analysis. If a simple slope,height, area, > moment (SHAM) characterization is sufficient WinNonlin will work in this > case. Wonderful! I think the SHAM acronym is a very appropriate description term for this kind of Cmax,Tmax,AUC PK analysis (aka Walt Disney School of PK Methodology). > My opinion, and no doubt that of the collective group of participants on > this list, is that a model based analysis is the most suitable > approach. We must not forget that SHAM PK is model based but not compartmental. A structural PK model which can describe the full time course of concentrations should be a primary goal of PK analysis. SHAM analyses discard a lot of this information by integrating out time or only considering design specific aspects. > I think the only debate on the issue is whether this is true > 100% percent of the time or in a large majority of cases. Furthermore, > in most cases you will get more value from your data using a population > approach. If there is more than 1 subject then we should be considering a population approach. Apart from the target concentration intervention setting (aka TDM) this means all PK analyses (and indeed any other kind of model based analysis) should be viewed from a population perspective. -- Nick Holford, Divn Pharmacology & Clinical Pharmacology University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New Zealand email:n.holford@auckland.ac.nz tel:+64(9)373-7599x6730 fax:373-7556 http://www.phm.auckland.ac.nz/Staff/NHolford/nholford.htm