Fundamentals of Pharmacology Lecture 1

Pharmacokinetics vs pharmacodynamics

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* What is a Drug

Most broad definition: chemical entity that affects a living protoplasm

Difference between drug and medicine

Medicine is a kind of drug – used to treat, cure, prevent or diagnose disease

What is Pharmacology

Study of drugs and medicine

Very broad

Includes chemistry, biology, biochemistry, physiology, pathology, pathophysiology, molecular biology, enzymology, genetics

Every aspect of how a drug interfaces with the human body – what it is about the drug and how that interplays with normal bodily functions

Disease relevant targets, selection of drug to manipulate the target, evaluate the response, maximize specificity of the response, minimize toxicity, prove it works

Constantly evolving, multiple disciplines, multiple levels

We know that environment significantly changes a person’s response to a drug; also, no two humans respond to drugs in the same way (personalized medicine)

Interaction between genes and environment is important as well

How are Drugs Developed

First, pre-clinical testing and R&D

Average 18 months (1-3 years)

Discovery, initial synthesis, purification

Drug discover phase

Followed by exposing animals to the drug molecule to attempt to determine how the drug might work, if the drug will work, and if the drug is safe

Surrogate animal models

FDA – gives permission for investigators to start testing drug on humans

Phase 1, phase 2, and phase 3 of testing on humans – focused on trying to define pharmacokinetics (phase 1), pharmacodynamics (phase 2), and then impact of drug on clinical outcome (phase 3)

At this stage, the drug is still investigational – must undergo review again for FDA to discern whether drug is safe for use in populations

If drug is approved, evaluate impact drug safety and efficacy

Pharmacology

In US alone, more than 4 billion prescriptions written in 2011 ($320 billion)

Drug therapy is used in the treatment of almost all diseases

Aim...