Access the full text.
Sign up today, get DeepDyve free for 14 days.
P. Lutze, A. Román-Martínez, J. Woodley, R. Gani (2012)
A systematic synthesis and design methodology to achieve process intensification in (bio) chemical processesComput. Chem. Eng., 36
Richard Lalonde, K. Kowalski, M. Hutmacher, Wayne Ewy, D. Nichols, P. Milligan, B. Corrigan, P. Lockwood, S. Marshall, L. Benincosa, T. Tensfeldt, K. Parivar, M. Amantea, P. Glue, H. Koide, Raymond Miller (2007)
Model‐based Drug DevelopmentClinical Pharmacology & Therapeutics, 82
S Allerheiligen (2010)
Next‐Generation Model‐Based Drug Discovery and Development: Quantitative and Systems PharmacologyClinical Pharmacology & Therapeutics, 88
J. Gobburu, L. Lesko (2009)
Quantitative disease, drug, and trial models.Annual review of pharmacology and toxicology, 49
J. Powell, J. Gobburu (2007)
Pharmacometrics at FDA: Evolution and Impact on DecisionsClinical Pharmacology & Therapeutics, 82
J. Wetherington, M. Pfister, C. Banfield, J. Stone, R. Krishna, S. Allerheiligen, D. Grasela (2010)
Model‐Based Drug Development: Strengths, Weaknesses, Opportunities, and Threats for Broad Application of Pharmacometrics in Drug DevelopmentThe Journal of Clinical Pharmacology, 50
L. Sheiner (1997)
Learning versus confirming in clinical drug developmentClinical Pharmacology & Therapeutics, 61
R. Keizer, J. Schellens, J. Beijnen, A. Huitema (2011)
Pharmacodynamic biomarkers in model-based drug development in oncology.Current clinical pharmacology, 6 1
S. Suryawanshi, Liping Zhang, M. Pfister, B. Meibohm (2010)
The current role of model-based drug developmentExpert Opinion on Drug Discovery, 5
[Large scale in silico clinical development will only become a reality after some effort is exerted; some partial solutions (SB and BI tools mentioned in previous chapters) already exist and first attempts have been made. We acknowledge here that we are NOT in square zero and that in silico technologies have been, and are already being, used in clinical trial design and execution, used in simulation studies for adaptive trials, and used to identify patient subpopulations and markers for enrichment strategies. This goal will require a concentrated effort by all players, with considerable investment from the pharma industry and governments.]
Published: Jan 4, 2012
Keywords: Clinical Trial Design; Learning Cycle; Process Analytical Technology; Enrichment Strategy; Adaptive Trial
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.