Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims

CPT: Pharmacometrics and Systems Pharmacology

Volumn 2, Issue 2, 2013, Pages

  Marshall, S F ^a   Hemmings, R ^b,c   Josephson, F ^b,d   Karlsson, M O ^e   Posch, M ^b,g   Steimer, J L ^f  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^d MEDICAL PRODUCTS AGENCY   (Sweden)

^e UPPSALA UNIVERSITY   (Sweden)

^f NOVARTIS PHARMA AG   (Switzerland)

^g MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

CASE STUDY; DISEASE COURSE; EXPERIMENTAL DESIGN; MODEL; NONLINEAR REGRESSION ANALYSIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; SIMULATION; STATISTICAL ANALYSIS;

EID: 84881136062     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.4     Document Type: Review

References (12)

1. Manolis, E. & Herold, R. Pharmacometrics for regulatory decision making. Br. J. Clin. Pharmacol. 50, P625-P626 (2011).
2. Jonsson, S., Henningsson, A., Edholm, M. & Salmonson, T. Role of modelling and simulation: a European regulatory perspective. Clin. Pharmacokinet. 51, 69-76 (2011).
3. Manolis, E., Rohou, S., Hemmings, R., Karlsson, M.O. & Milligan, P.A. The role of modelling and simulation in development and registration of medicinal products: output from the EFPIA/EMA modelling and simulation workshop. Pharmacomet. Syst. Pharmacol., this issue.
4. Holford, N.H. & Peace, K. The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials. Eur. J. Clin. Pharmacol. 47, 17-23 (1994). (Pubitemid 24281306)
5. Chan, P.L., Nutt, J.G. & Holford, N.H. Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation. Pharm. Res. 24, 791-802 (2007). (Pubitemid 46411968)
6. European Medicines Agency. Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias [document reference CPMP/EWP/553/95 Rev. 1; online]. . Accessed 14 September 2012.
7. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease [document reference: EMA/CHMP/330418/2012 rev. 2;online]. . Accessed 14 September 2012.
8. European Medicines Agency. Risk benefit methodology assessment project. .
9. Harnisch, L., Shepard, T., Pons Pons, G. & Della Pasqua, O. Modeling and simulation as a tool to bridge efficacy and safety data in special populations. CPT: Pharmacomet. Syst. Pharmacol. 2, e28 (2013).
10. Modelling Resources (DDMoRe)-.
11. Campaign Against Major Diseases (CAMD). .
12. Visser, S.A.G., Manolis, E., Danhof, M. & Kerbusch, T. Modeling and simulation at the interface of nonclinical and early clinical drug development. CPT: Pharmacomet. Syst. Pharmacol. 2, e30 (2013).