1. PMCY 4200-Pharmaceutical Sciences II Arthur G. Roberts

2. Résumé General Skills – Pharmacokinetics/Pharmacodynamics (PKPD) Calculations Computer Skills – PKPD software: Phoenix WinNonLin

3. Pharmwiki

4. Class Facebook

6. Optional

7. Don’t Need to Memorize

8. Will Be Provided

9. Beginning of Each Chapter: Tells you what you need to know

10. End of Chapter: Problems for Students End of Book: Answers

11. Other Undergraduate vs. Graduate (MS) Extra points – 1 point Mistakes in the lectures and other materials Contradict myself Spelling errors for drugs or enzymes – 0.5 point Serious grammatical errors Information is Cummulative

12. Undergraduate vs. Masters Undergraduate – Multiple choice and Fill-in – Straight-forward math problems- Excel worksheet (“Plug and Chug”) Masters – All the undergraduate stuff + – Problems from the back of the Chapters – Pheonix WinNonLin project

13. Phoenix WinNonLin Industry standard for Pharmacokinetic and Pharmacodynamic Modeling- Something to put on your résumé.

14. MS Students: Phoenix WinNonLin Project Goals (Due next week) Get login and password at end of class. Go to www.pharmwiki.org for Phoenix instructions Download and install Microsoft Remote Desktopwww.pharmwiki.org Put a folder link on your remote desktop to your computer Get Phoenix licensing to work. You will show me at the end of class next week that you can do it.

15. Teaching Style

16. THERAPEUTIC RELAVENCE Lecture #1

18. Pharmacon Pharmacokinetics How the body handles a drug over time Pharmacodynamics How the drug affects the body over time

19. [Drug] in the blood plasma Red blood cell count Level of pain relief Drug removal rate in the urine Absorption rate in the stomach Tumor reduction level

22. Plateaus

23. Warfarin Time Delays: Administration vs. Response

24. Time Delays: Fraction of Leukocytes Paclitaxel

25. Pharmacokinetic Variability

26. Pharmacodynamic Variability

27. Nonadherence

29. 3-6 Years 6-7 Years 0.5-2 Phase I 5,000 -10,000 250 5 1 Phase 2 Phase 3 Find Targets DiscoveryPreclinical Clinical Volunteers 20 -100 100 -500 1,000 -5,000 FDAScale-up Market Innovation.org and DiMasi, et al. 2003 *Inflation Adjusted $420 million* $585 million* Total= >$1 billion Industrial Perspective