PMCY 4200-Pharmaceutical Sciences II

Arthur G. Roberts

Résumé

• General Skills– Pharmacokinetics/Pharmacodynamics (PKPD)

Calculations• Computer Skills– PKPD software: Phoenix WinNonLin

Pharmwiki

Class Facebook

Optional

Don’t Need to Memorize

Will Be Provided

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

End of Chapter: Problems for Students

End of Book: Answers

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

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

Phoenix WinNonLin• Industry standard for Pharmacokinetic and

Pharmacodynamic Modeling- Something to put on your résumé.

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 Desktop

• 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.

Teaching Style

THERAPEUTIC RELAVENCELecture #1

• Pharmacon• Pharmacokinetics• How the body handles a drug over time

• Pharmacodynamics• How the drug affects the body over time

• [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

Plateaus

Warfarin

Time Delays: Administration vs. Response

Time Delays: Fraction of LeukocytesPaclitaxel

Pharmacokinetic Variability

Pharmacodynamic Variability

Nonadherence

3-6 Years 6-7 Years 0.5-2

Phase I

5,000-10,000

250 51

Phase 2 Phase 3

Find

Tar

gets

Discovery Preclinical Clinical

Volunteers

20-100

100-500

1,000-5,000

FDA Scale-up

Market

Innovation.org and DiMasi, et al. 2003*Inflation Adjusted

$420 million* $585 million* Total= >$1 billion

Industrial Perspective

Industrial Perspective