Proposed best practice for projects that involve modelling and simulation

Pharmaceutical Statistics

Volumn 16, Issue 2, 2017, Pages 107-113

  O'Kelly, Michael ^a   Anisimov, Vladimir ^b   Campbell, Chris ^c   Hamilton, Sinéad ^a  

^a IQVIA   (United States)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c Mango Solutions ^*  (United Kingdom)

Author keywords

best practice; modelling and simulation; Monte Carlo technique; pre specification; quality control

Indexed keywords

DRUG INDUSTRY; HUMAN; MONTE CARLO METHOD; PHYSICIAN; QUALITY CONTROL; STATISTICAL MODEL; COMPUTER SIMULATION; METHODOLOGY; PROCEDURES;

COMPUTER SIMULATION; DRUG INDUSTRY; HUMANS; MODELS, STATISTICAL; MONTE CARLO METHOD; QUALITY CONTROL; RESEARCH DESIGN;

EID: 84997542860     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1789     Document Type: Article

References (11)

1. European Medicines Agency. EFPIA-EMA Modelling and Simulation Workshop Report. EMA-EFPIA Modelling and Simulation Workshop: London, 2011. Available at http://www.ema.europa.eu/docs/enGB/documentlibrary/Report/2012/05/WC500127118.pdf. (Accessed 31 March 2016).
2. R. Hemmings, M&S Good Practices and Next Steps. EMA-EFPIA Modelling and Simulation Workshop: London, 2011. Available at https://www.youtube.com/watch?v=BSsaUmMuUAE&index=12&list=PL7K5dNgKnawY96v4FlgjTwUFAgUCXrRmw. (Accessed 31 March 2016).
3. V. V. Anisimov, V. V. Fedorov, Modelling, prediction and adaptive adjustment of recruitment in multicentre trials. Stat Med. 2007, 26, 4958–4975.
4. R. Cook, S. Weisberg, Applied Regression Including Computing and Graphics. John Wiley and Sons: Chichester, 1999.
5. A. Burton, D. Altman, P. Royston, R. Holder, The design of simulation studies in medical statistics. Stat Med. 2006, 25, 4279–4292.
6. N. Holford, M. Hale, H. Ko, J.-L. Steimer, L. Sheiner, C. Peck, P. Bonate, W. Gillespie, T. Ludden, D. Rubin, D. Stanski. Simulation in drug development: good practices. 1999. Originally published by the Centre for Drug Development Science (CDDS). Available at http://holford.fmhs.auckland.ac.nz/docs/simulation-in-drug-development-good-practices.pdf. Accessed 10 October 2016.
7. US Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. In Guidance for industry: population pharmacokinetics. US Food and Drug Administration: Rockville, MD, 1999.
8. B. Gaydos, K. Anderson, D. Berry, N. Burnham, C. Chuang-Stein, J. Dudinak, P. Fardipoor, P. Gallo, S. Givens, R. Lowis, J. Maca, J. Pinheiro, Y. Pritchett, M. Krams, Good practices for adaptive clinical trials. Drug Inf J. 2009, 43, 539–556.
9. M. Smith, A. Marshall, Importance of protocols for simulation studies in clinical drug development. Stat Methods Med Res. 2010, 20, 613–622.
10. C.-F. Burman, S. Wiklund, Modelling and simulation in the pharmaceutical industry—some reflections. J Chem Pharm Res. 2011, 10, 508–516.
11. S. Marshall, R. Burghaus, V. Cosson, S. Cheung, M. Chenel, O. DellaPasqua, N. Frey, B. Hamren, L. Harnisch, F. Ivanow, T. Kerbusch, J. Lippert, P. Milligan, S. Rohou, A. Staab, J. Steimer, C. Tornøe, S. Visser, Good Practices in Model-Informed Drug Discovery and Development (MID3): practice, application and documentation. Pharmacometrics Syst Pharmacol. 2016, 5, 93–122. doi: 10.1002/psp4.12049.