RE: End of semester MCQ and short answer question
From: mmunsaka@tgrd.com
Subject: RE: [NMusers] End of semester MCQ and short answer question
Date: Fri, July 15, 2005 8:50 am
Hello,
I am also interested in this question and I a currently looking into this question.
I have the following additional references (simple latex syntax) if this may be of
use to you (and you have not already seen these). I don't think I have seen any
regulatory recommendations on this issue and would be curious as to what the
agencies think. I am also interested in other references that other people may have.
Melvin Munsaka, PhD
Takeda Global Research & Development Center, Inc.
=======================================\begin{thebibliography}{99}
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Solving the bias problem in censored pharmacokinetic data.
\emph{ http://pubhealth.ku.dk/upload/application/pdf/f51d6748/rr-05-5.pdf}.
\bibitem{Duval} Duval, V. and Karlsson, M. O. (2002). Impact of omission
of data below the limit of quantification on parameter estimates in
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(1989). The influence of assay variability on pharmacokinetic
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571-592.
\bibitem{Jackson} Jackson,A. J. (1992). Inappropriate inclusion of
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of absorption. \emph{Biopharm. Drug Disp.}, \textbf{15}, 629-634.
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(2001). Analysis of toxicokinetics data using {NONMEM}: {I}mpact of
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\emph{J. Pharmacok. Pharmacod.} \textbf{28}, 465-479.
\bibitem{Hoffman} Hoffman, W. P., Heathman, M. A., Chou, J. Z., and
Allen, D. L. (200X?). Analysis of toxicokinetic and pharmacokinetic
data from anaimal studies. In S. P. Millard and A. Krause (eds),
\emph{Applied Statistics in the Pharmaceutical Industry With Case
Studies Using S-Plus}. Chapter 4.
\bibitem{Humbert} Humbert, H., Cabiac, M. D., Barradas, J., and Gerbeau, C.
(1996). Evaluation of pharmacokinetic studies: {Is} it useful to
take into account concentrations below the limit of quantification?.
\emph{Pharm. Res.}, \textbf{13}, 839-845.
\bibitem{Sadler} Sadler, W. A. and Smith, M. H. (1990). Use and
abuse of imprecsion profiles: some pitfalls illustrated bu computing
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1346-1350.
\bibitem{Tod} Tod, M (2005). Handling concentrations below quantification
limit in population. Presentation at the 2005 PAGE Meeting.