NIH Clinical Center: Schedule/Syllabus

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Principles of Clinical Pharmacology: Schedule/Syllabus

2008-2009 Course Schedule

All sessions will meet Thursday evenings from 6:30 p.m. to approximately 7:45 p.m. Eastern time in the NIH Clinical Center, Building 10, in the Lipsett Amphitheater in Bethesda, Maryland.

If you experience any accessibility problems with the PDFs below, please contact (301) 496-9425 or email CC-OD_Clinp@mail.cc.nih.gov

September 4	Introduction to course Introduction Slides (1 slide per page) Introduction Slides (3 slides per page) Introduction Slides (Text-Only) Video of Introduction to course from previous year lecture with caption	J. Lertora (NIH/CC)
MODULE 1: PHARMACOKINETICS
September 11	Clinical pharmacokinetics Clinical Pharmacokinetics Slides (1 slide per page) Clinical Pharmacokinetics Slides (3 slides per page) Clinical Pharmacokinetics Slides (Text-Only) Video of Clinical pharmacokinetics from previous year lecture with caption	J. Lertora (NIH/CC)
September 18	Chemical assay of drugs and drug metabolites Chemical Assay Slides (1 slide per page) Chemical Assay Slides (3 slides per page) Chemical Assay Slides (Text-Only) Video of Chemical assay of drugs and drug metabolites from previous year lecture with caption	S. Markey (NIH/NIMH)
September 25	Compartmental analysis of drug distribution Compartmental analysis of drug distribution slides (1 slide per page) Compartmental analysis of drug distribution slides (3 slides per page) Compartmental analysis of drug distribution slides (Text-Only) Video of compartmental analysis of drug distribution from previous year lecture with caption	J. Lertora (NIH/CC)
October 2	Drug absorption and bioavailability Drug absorption and bioavailability slides (1 slide per page) Drug absorption and bioavailability slides (3 slides per page) Drug absorption and bioavailabilityslides (Text-Only) Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification Sytem. Video of drug absorption and bioavailability from previous year lecture with caption	J. Lertora (NIH/CC)
October 9	Use of positron emission tomography (PET) in pharmacokinetics Positron Emission Tomography slides (1 slide per page) Positron Emission Tomography slides (3 slides per page) Positron Emission Tomography slides (Text-Only) Video of Positron emission tomography (PET) from previous year lecture with caption PET from previous year Lecture -Video 1 PET from previous year Lecture -Video 2	R. Innis (NIH/NIMH)
October 16	Effects of renal disease on pharmacokinetics Effects of renal disease on pharmacokinetics (1 slide per page) Effects of renal disease on pharmacokinetics (3 slides per page) Effects of renal disease on pharmacokinetics (Text-Only) Video of Effects of Renal Disease on Pharmacokinetics with caption	J. Lertora (NIH/CC)
October 23	SPECIAL LECTURE: Pharmacokinetics in patients requiring renal replacement therapy Pharmacokinetics in patients requiring renal replacement therapy (Dr. Atkinsons's slides - 1 slide per page) Pharmacokinetics in patients requiring renal replacement therapy (Dr. Atkinsons's slides - 3 slides per page) Pharmacokinetics in patients requiring renal replacement therapy (Dr. Atkinsons's slides - Text-only) Pharmacokinetics in patients requiring renal replacement therapy (Dr. Susla's slides - 1 slide per page) Pharmacokinetics in patients requiring renal replacement therapy (Dr. Susla's slides - 3 slides per page) Pharmacokinetics in patients requiring renal replacement therapy (Dr. Susla's slides - Text-only) Video of pharmacokinetics in patients requiring hemodialysis from previous year lecture Video with caption Supplemental Reading: FDA Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing and Labeling. http://www.fda.gov/cder/guidance/1449fnl.pdf	A. Atkinson (Northwestern University) G. Susla (MedImmune, Inc)
October 30	Noncompartmental vs. compartmental approaches to PK analysis Noncompartmental vs. compartmental approaches to PK analysis (1 slide per page) Noncompartmental vs. compartmental approaches to PK analysis (3 slides per page) Noncompartmental vs. compartmental approaches to PK analysis (Text-only) Video of noncompartmental vs. compartmental approaches to PK data analysis with caption	P. Vicini (Pfizer, Inc.)
November 6	Effects of liver disease on pharmacokinetics Effects of liver disease on pharmacokinetics (1 slide per page) Effects of liver disease on pharmacokinetics (3 slides per page) Effects of liver disease on pharmacokinetics (Text-only) Supplemental Reading: FDA Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. http://www.fda.gov/cber/gdlns/imphep.pdf Video of effects of liver disease on pharmacokinetics from previous year lecture video with caption	J. Lertora (NIH/CC)
November 13	Population pharmacokinetics Population pharmacokinetics (1 slide per page) Population pharmacokinetics (3 slides per page) Population pharmacokinetics (Text-only) Video of population pharmacokinetics from previous year video with caption	R. Miller (Pfizer, Inc.)
MODULE 2: DRUG METABOLISM AND TRANSPORT
November 20	Pathways of drug metabolism Pathways of drug metabolism (1 slide per page) Pathways of drug metabolism (3 slides per page) Pathways of drug metabolism (Text-only) Video of pathways of drug metabolism from previous year lecture video with caption	S. Markey (NIH/NIMH)
December 4	Pharmacogenomics Pharmacogenomics (1slide per page) Pharmacogenomics (3 slides per page) Pharmacogenomics (Text-only) Video of pharmacogenetics from previous year lecture video with caption	D. Flockhart (IUPUI)
December 11	Drug Interactions Drug Interactions (1 slide per page) Drug Interactions (3 slides per page) Drug Interactions (Text-only) Video of drug interactions from previous year lecture video with caption	S. Penzak (NIH/CC)
December 18	Biochemical mechanisms of drug toxicity Biochemical mechanisms of drug toxicity (1 slide per page) Biochemical mechanisms of drug toxicity (3 slides per page) Biochemical mechanisms of drug toxicity (Text-only) Video of Biochemical mechanisms of drug toxicity from previous year lecture video with caption	L. Pohl (NIH/NHLBI)
January 8	Equilibrative and concentrative transport Equilibrative and concentrative transport (1 slide per page) Equilibrative and concentrative transport (3 slides per page) Equilibrative and concentrative transport (Text-only) Video of Equilibrative and concentrative transport from previous year lecture video with caption	J. Ware (Genentech, Inc.)
January 15	SPECIAL LECTURE: P-glycoprotein and drug transport Dr. Innis's slides from previous year lecture Dr. Gottesman's slides from previous year lecture Video of P-glycoprotein and drug transport from previous year lecture video with caption	M. Gottesman (NIH/OIR) R. Innis (NIH/NIMH)
MODULE 3: ASSESSMENT OF DRUG EFFECTS:
January 22	Dose response and concentration response analysis Slides of Dose response and concentration response analysis from previous year lecture Video of Dose response and concentration response analysis from previous year lecture video with caption	F. Balis (NIH/NCI)
January 29	Disease progression models and clinical trial simulation Slides of disease progression models and clinical trial simulation from previous year lecture Video of disease progression models and clinical trial simulation from previous year lecture	D. Mould (Projections Research, Inc.)
February 5	Physiological and laboratory markers of drug effect Slides of physiological and laboratory markers of drug effect from previous year lecture Video of physiological and laboratory markers of drug effect from previous year lecture video with caption	J. Woodcock (FDA)
MODULE 4: Optimizing and Evaluating Patient Therapy
February 12	Drug therapy in pregnant and nursing women Slides of drug therapy in pregnant and nursing women from previous year lecture Video of drug therapy in pregnant and nursing women from previous year lecture	M. Frederiksen (Northwestern University)
February 19	Developmental and pediatric pharmacology Slides of developmental and pediatric pharmacology from previous year lecture Video of developmental and pediatric pharmacology previous year lecture video with caption	F. Balis (NIH/NCI)
February 26	Drug therapy in the elderly Slides of drug therapy in the elderly previous year lecture Video of drug therapy in the elderly previous year lecture video with caption	D. Abernethy (U.S. Pharmacopeia)
March 5	Quality assessment of drug therapy Slides of quality assessment of drug therapy previous year lecture video with caption Video of quality assessment of drug therapy previous year lecture video with caption	C. Daniels (UCSD)
March 12	Clinical analysis of adverse drug reactions Slides of clinical analysis of adverse drug reactions previous year lecture Video of clinical analysis of adverse drug reactions previous year lecture video with caption	K. Calis (NIH/CC)
MODULE 5: DRUG DISCOVERY AND DEVELOPMENT
March 19	Drug discovery Slides of drug discovery previous year lecture Video of drug discovery previous year lecture video with caption	E. Sausville (UMMS)
March 26	Pre-clinical drug development Slides of pre-clinical drug development previous year lecture Video of pre-clinical drug development previous year lecture video with caption	C. Takimoto (Centocor R&D, Inc., Johnson & Johnson)
April 2	Animal scale up and Phase I studies Dedrick Slides for Animal scale up and Phase I studies previous year lecture Collins Slides for Animal scale up and Phase I studies previous year lecture Animal scale up and Phase I studies from previous PCP course Dr. Dedrick's previous year lecture Video with caption Dr. Collins' previous year lecture Video with caption	R. Dedrick (NIH/NIBIB) J. Collins (NIH/NCI)
April 9	Pharmacokinetics of biotechnology products and large molecules Slides of pharmacokinetics of biotechnology products and large molecules from previous year lecture Video of pharmacokinetics of biotechnology products and large molecules from previous year lecture video with caption	P. Garzone (PD3G Consulting)
April 16	Design of clinical drug development programs Slides of design of clinical drug development program from previous year lecture Video of design of clinical drug development program from previous year video with caption	C. Grudzinskas (NDA Partners, LLC and CDDS, UCSF)
April 23	Role of the FDA in guiding drug development Slides of role of the FDA in guiding drug development previous year lecture Video of role of the FDA in guiding drug development from previous year lecture video with caption	C. Peck (CDDS, UCSF)

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MODULE 1: PHARMACOKINETICS

MODULE 2: DRUG METABOLISM AND TRANSPORT

MODULE 3: ASSESSMENT OF DRUG EFFECTS:

MODULE 4: Optimizing and Evaluating Patient Therapy

MODULE 5: DRUG DISCOVERY AND DEVELOPMENT