This report highlights the main points emerging from a meeting sponsored on “Getting the Dose Right” in clinical development, jointly sponsored by the European Federation of Pharmaceutical Sciences and the European Center of Pharmaceutical Medicine, as part of the Workshop Series on Frontiers in Drug Development, in Basel, Switzerland on December 9–12, 2002.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
L.J. Lesko M. Rowland C.C. Peck T.F. Blaschke (2000) ArticleTitleOptimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans Eur. J. Pharm. Sci. 10 iv–xiv Occurrence Handle11023342 Occurrence Handle1:CAS:528:DC%2BD3cXksFehsbs%3D Occurrence Handle10.1016/S0928-0987(00)00092-0
P. Rolan A.J. Atkinson SuffixJr L.J. Lesko (2003) ArticleTitleUse of biomarkers from drug discovery through clinical practice: Report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development Clin. Pharmacol. Ther. 73 284–291 Occurrence Handle10.1016/S0009-9236(02)17625-9 Occurrence Handle12709718
G.T. Tucker J.B. Houston S.W. Huang (2001) ArticleTitleOptimizing drug development: strategies to assess drug metabolism/transporter interaction potential-toward a consensus Eur. J. Pharm. Sci. 13 417–428 Occurrence Handle11480400 Occurrence Handle1:CAS:528:DC%2BD3MXlt1Crtrg%3D
Arlington S., S. Barnett, S. Hughes, and J. Palo. Pharma 2010: The Threshold of Innovation. IBM Business Consulting Services, 2002
J. Cross H. Lee Westelinck A.J. Nelson C. Grudzinkas C. Peck (2002) ArticleTitlePost- marketing drug dosage changes of 499 FDA-approved new molecular entities, 1980–1999 Pharmacoepidemiol. Drug Safety 11 439–446 Occurrence Handle10.1002/pds.744
L.B. Sheiner (1997) ArticleTitleLearning vs. confirming in clinical drug development Clin Pharmacol. Ther. 61 275–291 Occurrence Handle1:STN:280:DyaK2s3jvVWitQ%3D%3D
Leiden/Amsterdam Center for Drug Research conferences in Noordwijkerhout, 1990, 1994, 1998, 2002
L.B. Sheiner J.L. Steimer (2000) ArticleTitlePharmacokinetic and pharmacodynamic modeling in drug development Ann. Rev. Pharmacol. Toxicol. 40 67–95 Occurrence Handle1:CAS:528:DC%2BD3cXjs1yhsrg%3D
N.H.G. Holford H.C. Kimko J.P.R. Monteleone C.C. Peck (2000) ArticleTitleSimulation of clinical trials Ann. Rev. Pharmacol. Toxicol. 40 209–234 Occurrence Handle1:CAS:528:DC%2BD3cXjs1yhsLw%3D Occurrence Handle10.1146/annurev.pharmtox.40.1.209
http://www.fda.gov/cder/guidance/index.htm • ICH E-4: Dose-Response Information to Support Drug Registration (1994) • Exposure Response Relationships: Study Design, Data Analysis and Regulatory Applications (2003) • Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998)
S.A. Visser D.R. Huntjens P.H. Graaf Particlevan der L.A. Peletier M. Danhof (2003) ArticleTitleMechanism-based modeling of the pharmacodynamic interaction of alphaxalone and midazolam in rats J. Pharmacol. Exp. Ther. 307 765–775 Occurrence Handle10.1124/jpet.103.054510 Occurrence Handle12975494 Occurrence Handle1:CAS:528:DC%2BD3sXos1ShsLo%3D
M. Danhof S.A. Visser (2002) ArticleTitleand pharmacokinetic-pharmacodynamic modeling in drug development Methods Find. Exp. Clin. Pharmacol. 24 IssueIDsuppl D 127–128 Occurrence Handle12585231
M. Krams K.R. Lees W. Hacke A.P. Grieve J.M. Orgogozo G.A. Ford (2003) ArticleTitleAcute stroke therapy by inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke Stroke 34 2543–2548 Occurrence Handle10.1161/01.STR.0000092527.33910.89 Occurrence Handle14563972 Occurrence Handle1:CAS:528:DC%2BD3sXosFCgtro%3D
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Stanski, D.R., Rowland, M. & Sheiner, L.B. Getting the Dose Right: Report From the Tenth European Federation of Pharmaceutical Sciences (EUFEPS) Conference on Optimizing Drug Development. J Pharmacokinet Pharmacodyn 32, 199–211 (2005). https://doi.org/10.1007/s10928-005-0010-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10928-005-0010-x