Skip to main content
Top
Published in:
Cover of the book

2017 | OriginalPaper | Chapter

1. Introduction

Authors : Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri

Published in: Phase II Clinical Development of New Drugs

Publisher: Springer Singapore

Activate our intelligent search to find suitable subject content or patents.

search-config
loading …

Abstract

Most of the drugs available in pharmacy started out as a chemical compound or a biologic discovered in laboratories.

Dont have a licence yet? Then find out more about our products and how to get one now:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

  • über 102.000 Bücher
  • über 537 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Maschinenbau + Werkstoffe
  • Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Springer Professional "Wirtschaft"

Online-Abonnement

Mit Springer Professional "Wirtschaft" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 340 Zeitschriften

aus folgenden Fachgebieten:

  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Versicherung + Risiko




Jetzt Wissensvorsprung sichern!

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 390 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Maschinenbau + Werkstoffe




 

Jetzt Wissensvorsprung sichern!

Literature
go back to reference Cappelleri, J. C., & Spielberg, S. P. (2015). Advances in clinical outcome assessments. Therapeutic Innovation & Regulatory Science, 49, 780–782.CrossRef Cappelleri, J. C., & Spielberg, S. P. (2015). Advances in clinical outcome assessments. Therapeutic Innovation & Regulatory Science, 49, 780–782.CrossRef
go back to reference Cappelleri, J. C., Zou, K. H., Bushmakin, A. G., Alvir, J. M. J., Alemayehu, D., & Symonds, T. (2013). Patient-reported outcomes: Measurement, implementation and interpretation. Boca Raton, Florida: Chapman & Hall/CRC Press. Cappelleri, J. C., Zou, K. H., Bushmakin, A. G., Alvir, J. M. J., Alemayehu, D., & Symonds, T. (2013). Patient-reported outcomes: Measurement, implementation and interpretation. Boca Raton, Florida: Chapman & Hall/CRC Press.
go back to reference Chow, S. C., & Liu, J. P. (1999). Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker, Inc.MATH Chow, S. C., & Liu, J. P. (1999). Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker, Inc.MATH
go back to reference Crowley, J., & Hoering, A. (2012). Handbook of statistics in clinical oncology (3rd ed.). Boca Raton, FL: Chapman & Hall/CRC Press. Crowley, J., & Hoering, A. (2012). Handbook of statistics in clinical oncology (3rd ed.). Boca Raton, FL: Chapman & Hall/CRC Press.
go back to reference Doward, L.C., Gnanasakthy, A., & Baker, M.G. (2010). Patient reported outcomes: Looking beyond the claim. Health and Quality of Life Outcomes, 8, 89 (Open access). Doward, L.C., Gnanasakthy, A., & Baker, M.G. (2010). Patient reported outcomes: Looking beyond the claim. Health and Quality of Life Outcomes, 8, 89 (Open access).
go back to reference Drummon, M. F., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. (2005). Methods for the economic evaluation of health care programmes (3rd ed.). New York, NY: Oxford University Press. Drummon, M. F., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. (2005). Methods for the economic evaluation of health care programmes (3rd ed.). New York, NY: Oxford University Press.
go back to reference Fairclough, D. L. (2004). Patient reported outcomes as endpoints in medical research. Statistical Methods in Medical Research, 13, 115–138.CrossRefMATHMathSciNet Fairclough, D. L. (2004). Patient reported outcomes as endpoints in medical research. Statistical Methods in Medical Research, 13, 115–138.CrossRefMATHMathSciNet
go back to reference Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials (2nd ed.). Boca Raton, Florida: Chapman & Hall/CRC.MATH Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials (2nd ed.). Boca Raton, Florida: Chapman & Hall/CRC.MATH
go back to reference Finney, D. J. (1978). Statistical methods in biological assay (3rd ed.). London: Charles Griffin.MATH Finney, D. J. (1978). Statistical methods in biological assay (3rd ed.). London: Charles Griffin.MATH
go back to reference Glick, H. A., Doshi, J. A., Sonnad, S. S., & Polsky, D. (2005). Economic evaluation in clinical trials (2nd ed.). New York, NY: Oxford University Press. Glick, H. A., Doshi, J. A., Sonnad, S. S., & Polsky, D. (2005). Economic evaluation in clinical trials (2nd ed.). New York, NY: Oxford University Press.
go back to reference Green, S., & Benedetti, J. (2012). Clinical trials in oncology (3rd ed.). Boca Raton, FL: Chapman & Hall/CRC Press. Green, S., & Benedetti, J. (2012). Clinical trials in oncology (3rd ed.). Boca Raton, FL: Chapman & Hall/CRC Press.
go back to reference ICH-E4. (1994). Harmonized tripartite guideline dose-response information to support drug registration. ICH-E4. (1994). Harmonized tripartite guideline dose-response information to support drug registration.
go back to reference Morrow, T. (2004). Defining the difference: What makes biologics unique. Biotechnology Healthcare, 24–29. Morrow, T. (2004). Defining the difference: What makes biologics unique. Biotechnology Healthcare, 24–29.
go back to reference Muenning, P. (2007). Cost-effectiveness analysis in health: A practical approach (2nd ed.). San Francisco, California: Jossey-Bass. Muenning, P. (2007). Cost-effectiveness analysis in health: A practical approach (2nd ed.). San Francisco, California: Jossey-Bass.
go back to reference Selwyn, M.R. (1988). Preclinical safety assessment. In K.E. Peace (Ed.), Biopharmaceutical statistics for drug development. New York: Marcel Dekker, Inc. Selwyn, M.R. (1988). Preclinical safety assessment. In K.E. Peace (Ed.), Biopharmaceutical statistics for drug development. New York: Marcel Dekker, Inc.
go back to reference Ting, N. (2003). Drug development, encyclopedia of biopharmaceutical statistics (2nd ed., pp. 317–324). Marcel Dekker. Ting, N. (2003). Drug development, encyclopedia of biopharmaceutical statistics (2nd ed., pp. 317–324). Marcel Dekker.
go back to reference Ting, N. (2006). Introduction and drug development process, dose finding in drug development (pp. 1–17). New York: Springer. Ting, N. (2006). Introduction and drug development process, dose finding in drug development (pp. 1–17). New York: Springer.
Metadata
Title
Introduction
Authors
Naitee Ting
Ding-Geng Chen
Shuyen Ho
Joseph C. Cappelleri
Copyright Year
2017
Publisher
Springer Singapore
DOI
https://doi.org/10.1007/978-981-10-4194-5_1

Premium Partner