SCHOOL OF MEDICINE

Department of Medicine

Clinical Pharmacology

Didactic Program

The classes for our Didactic Program are held on Friday mornings from 10:30 am - 12:00 pm in our Clinical Pharmacology Conference Room (R2, Room 401).  Our fellows are required to attend the classes in each portion of our program.  We typically cover one topic per semester (two per year).  The topics we cover are:

DRUG MEASUREMENT

A series of lectures are presented on the quantification of drugs.  The goal of these lectures is to introduce fellows on how to quantify a drug.  The lectures start with different ways drugs are quantified, e.g. chromatography based or enzyme-linked immunosorbent assays.  More detailed discussions are presented on the use of chromatography for drug quantification.  Specifically, high performance liquid chromatography (HPLC) and gas chromatography (GC) are compared and contrasted, e.g. differences in hardware, mobile phases, detectors and columns, with multiple examples of each.  In addition, terms and topics used in chromatography-based assays are discussed in detail, e.g. resolution, crosstalk, the importance of peak separation, the use of gradient mobile phases in HPLC, and separation of isomers and enantiomers.  Next, sample preparation techniques are discussed.  These techniques include liquid-liquid extraction, solid phase extraction, protein precipitation and filtration procedures.   A detailed discussion is presented on the use of internal standardization, the standard response curve, how do you use the standard response curve to estimate unknown sample concentrations, etc.  Next, procedures used for a method validation (per FDA and EMA guidelines) are discussed.  These procedures include intra-day and inter-day accuracy and precision studies, recovery (or extraction efficiency) studies, matrix effects, and freeze-thaw stability studies.  The last major topic discussed is the use of dried blood spots (DBS) as an alternative matrix for drug measurement.   At the end of these lectures, the fellows will be able to scrutinize or critique a method in the literature and understand how to develop a method to quantify drugs for a study. 

 

PHARMACOKINETICS/PHARMACODYAMICS

The goals of the pharmacogenomics lectures are to get the trainees familiar with the major genetic variants that are known to alter hepatic drug metabolism and to understand the assays that are used to to detect them.   The pharmacogenomics section of the training program is focused on the impact of genetics on hepatic drug metabolism.  The introduction describes the clinical role of pharmacogenomics in drug therapy.  The methods in genetics includes discussions of the commonly used laboratory assays that are used for genotyping and interrogating genomes for both clinical and research purposes, including both the molecular biology aspects of the assays as well as regulatory aspects of clinical genotyping laboratories. We dedicate several discussions to the individual phase I and phase II drug metabolizing enzymes and drug transporters and how germline genetic variants affect the metabolism and prescribing of drug eliminated through those pathways. Lastly, we discuss the role of somatic tumor genomics on the selection of oncology therapies.  At the end of this series, the trainees should understand the background of pharmacogenomics and be familiar with the major drugs that undergo pharmacogenomics dependent hepatic metabolism.  

 

RESPONSE MODELING

Information coming soon.

 

PHARMACOGENOMICS

The goals of the pharmacogenomics lectures are to get the trainees familiar with the major genetic variants that are known to alter hepatic drug metabolism and to understand the assays that are used to to detect them.   The pharmacogenomics section of the training program is focused on the impact of genetics on hepatic drug metabolism.  The introduction describes the clinical role of pharmacogenomics in drug therapy.  The methods in genetics includes discussions of the commonly used laboratory assays that are used for genotyping and interrogating genomes for both clinical and research purposes, including both the molecular biology aspects of the assays as well as regulatory aspects of clinical genotyping laboratories. We dedicate several discussions to the individual phase I and phase II drug metabolizing enzymes and drug transporters and how germline genetic variants affect the metabolism and prescribing of drug eliminated through those pathways. Lastly, we discuss the role of somatic tumor genomics on the selection of oncology therapies.  At the end of this series, the trainees should understand the background of pharmacogenomics and be familiar with the major drugs that undergo pharmacogenomics dependent hepatic metabolism. 

 

BIOSTATISTICS

The biostatistics training part covers several commonly applied techniques. These include introduction to probability and statistics, two sample comparison methods, linear and ANOVA models, power and sample size analysis, and clinical trial design. Moreover, statistical methods to conduct genome wide association study (GWAS), next generation sequencing (NGS) analysis, and functional genomics analysis will be demonstrated with detailed examples. The training also include an introduction to statistical computing with R software.

 

CLINICAL TRIALS AND DRUG DEVELOPMENT

Information coming soon.

 

SPECIAL POPULATIONS

Information coming soon.

 

'OMICS'

Information coming soon.

 

OVERIEW OF SYSTEMS PHARMACOLOGY

Information coming soon.

 

Past Schedules: