Alan Maloney
  • Drug Development for Patients
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  1. Contact
  • Welcome
  • 1  Introduction
  • 2  My Background / Motivation (can be skipped)
  • 3  Why Patients Outcomes Must Come First
  • 4  A Brief History Of Drug Development; The Good, The Bad And The Ugly
  • 5  Dose Response Trials; A Brief History And Overview Of Current Practices
  • 6  The Science; Why We Must Care About Dose, Pharmacokinetics, Pharmacodynamics And Utility
  • 7  Introduction To IIV In PK And Its Consequences To D-E-R Trial Design
  • 8  Introduction To IIV In PD And D-E-R Analysis As Evidence For Regulators
  • 9  Personalised Dosing; Patients Are Different
  • 10  Where Does Precision Medicine And Personalised Medicine Fit In?
  • 11  Dose Response Modelling; Why We Need Integrated Analyses Across All Doses/Trials
  • 12  Introducing The Most Important Dose Response Model
  • 13  Population and Individual Dose-Exposure-Responses, Therapeutic Windows and Maximum Tolerated Doses
  • 14  What Should Be The Role For Regulators?
  • 15  The Two Regulatory Approval Pathways; “Approval P” and “Approval I”
  • 16  The Two Development Strategies; “Strategy P” and “Strategy I”
  • 17  Changing How We Pay For Drugs; Value/Outcome Based Pricing And Subscription Based Pricing
  • 18  What Product Should Drug Companies Sell? (can be skipped)
  • 19  Adaptive Randomisation In Population D-E-R Trials; Why We Should Learn As We Go
  • 20  The Half Time Summary; What Have We Learnt, And What Solutions Are Outstanding?
  • 21  Technical Sections To Write
  • 22  Conclusions
  • 23  Acknowledgements
  • Glossary
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Contact

I hope you have found this book both enjoyable and thought provoking, and that you look forward to seeing the remaining chapters.

I also hope it has inspired you to be an advocate for “Drug Development for Patients”.

If you would like to discuss anything with me, I can be contacted at the email address below. It would be nice to hear your thoughts.

Best wishes, Al