Dear all
I would like to apply pkpd-vd analysis to quantify the impact of
HAART(based) prophylaxis to the rate of mother to child transimission
and progression of HIV-1 in mother and child pairs expected to be
followed up for a minimum of 2 years. Can you please assist me on the
following issues:
1. What are the methods to use for determining the minimum number of
mother and newborn pairs to be included for pkpd-vd analysis?
2. What are the minimum number of blood samples and optimal sampling
times should i collect from both mother and newborn pairs to obtain an
accurate measure of the drug and viral load levels over the 2-year
period?
Primary covariates to be included in the analysis are CYP2B6, CYP3A4 and ABCB1.
Your comments and suggestions are welcome.
Regards
Bernard
PhD Student, University of Zimbabwe
--
Bernard Ngara
Trainee Biostatistician
Africa Institute of Biomedical Science and Technology
P. O Box 2294
Harare
Zimbabwe
+263 772 160 896
Sampling and sample size for pkpd analysis
Dear Bernard and all,
This is a few of the scientific papers on that topic that I am aware of:
Vong C, Bergstrand M, Nyberg J, Karlsson MO. Rapid sample size calculations for
a defined likelihood ratio test-based power in mixed-effects models. AAPS J.
2012 Jun;14(2):176-86.
Ogungbenro, K., Aarons, L. & Graham, G. Sample size calculations based on
generalized estimating equations for population pharmacokinetic experiments. J.
Biopharm. Stat. 16, 135-50 (2006).
Kang, D., Schwartz, J. B. & Verotta, D. Sample size computations for PK/PD
population models. J. Pharmacokinet. Pharmacodyn. 32, 685-701 (2005).
Lee, P. Design and power of a population pharmacokinetic study. Pharm. Res. 18,
75-82 (2001).
For the practical implementation of sample size calculations you can use the
MCMP or the SSE functionality in PsN:
http://psn.sourceforge.net/pdfdocs/mcmp_userguide.pdf
http://psn.sourceforge.net/pdfdocs/sse_userguide.pdf
Best regards,
Martin
Quoted reply history
-----Original Message-----
From: [email protected] [mailto:[email protected]] On
Behalf Of Bernard Ngara
Sent: den 17 februari 2015 17:39
To: [email protected]
Subject: [NMusers] Sampling and sample size for pkpd analysis
Dear all
I would like to apply pkpd-vd analysis to quantify the impact of
HAART(based) prophylaxis to the rate of mother to child transimission and
progression of HIV-1 in mother and child pairs expected to be followed up for a
minimum of 2 years. Can you please assist me on the following issues:
1. What are the methods to use for determining the minimum number of mother and
newborn pairs to be included for pkpd-vd analysis?
2. What are the minimum number of blood samples and optimal sampling times
should i collect from both mother and newborn pairs to obtain an accurate
measure of the drug and viral load levels over the 2-year period?
Primary covariates to be included in the analysis are CYP2B6, CYP3A4 and ABCB1.
Your comments and suggestions are welcome.
Regards
Bernard
PhD Student, University of Zimbabwe
--
Bernard Ngara
Trainee Biostatistician
Africa Institute of Biomedical Science and Technology P. O Box 2294 Harare
Zimbabwe
+263 772 160 896