Response to validation and assessment of predictive performance in simulation models of clinical trials

Clinical Pharmacology and Therapeutics

Volumn 89, Issue 4, 2011, Pages 488-

  Holford, N ^a   Ma, S C ^a   Ploeger, B A ^b,c  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b LAP and P Consultants BV   (Netherlands)

^c LEIDEN UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); LETTER; PREDICTION; PRIORITY JOURNAL; SIMULATION; VALIDATION PROCESS;

EID: 79952987892     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.321     Document Type: Letter

References (5)

1. Boessen, R., Knol, M.J., Groenwold, R.H.H. & Roes, K.C.B. Validation and assessment of predictive performance in simulation models of clinical trials. Clin. Pharmacol. Ther. 89, 487-488 (2011).
2. Holford, N.H.G., Hale, M., Ko, H.C., Steimer, J.-L., Sheiner, L.B. & Peck, C.C. Simulation in Drug Development: Good practices. http://bts.Ucsf. Edu/cdds/research/sddgpreport.Php (1999). Accessed 3 November 2010.
3. Holford, N., Ma, S.C. & Ploeger, B.A. Clinical trial simulation: a review. Clin. Pharmacol. Ther. 88, 166-182 (2010).
4. Lockwood, P., Ewy, W., Hermann, D. & Holford, N. Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect; an example in alzheimer's disease. Pharm. Res. 23, 2050-2059 (2006).
5. Brendel, K. et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? a survey of the literature from 2002 to 2004. Clin. Pharmacokinet. 46, 221-234 (2007). (Pubitemid 46425648)