Lecture 1 Flashcards
A chemical substance that affects living organisms and is used by clinicians to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition.
Drug
The ideal drug is a hypothetical concept that encapsulates the desired qualities of a medication. While no drug can perfectly meet all these criteria, these properties serve as a benchmark for drug development and evaluation.
Ideal Properties of Drugs
- Efficacy and Potency
- Safety and Selectivity
- Pharmacokinetics
- Stability and Compatibility
- Cost-Effectiveness
- Convenience
Refers to blood entry in Pharmacokinetics
Absorption
Refers to drug processing mainly by the liver
Metabolism
Refers to elimination through the kidneys, lungs or biliary exretion
Excretion
The ideal drug would be highly effective, safe, selective, and convenient, while also being affordable and easy to administer. While this is an ambitious goal, drug development efforts strive to create medications that come as close as possible to these ideals.
Out of every 10,000-15,000 new compounds identified during discovery,
FIVE are considered safe for testing in human volunteers. Only ONE of these compounds is typically APPROVED as a marketed drug.
How many years will it take for drug discovery and pre-clinical trial?
3-6 years
How long will it take for clinical trials (phase I to III)
6-7 years
How long does FDA Review, Manufacturing, and Phase IV Post-Approval take?
0.5 to 2 years
biological processes underlying a disease to identify potential targets, such as proteins or enzymes
Disease Understanding
targets are validated to ensure that interfering with them will likely have a therapeutic effect
Target Validation
Millions of compounds are screened to identify those that interact with the target
Screening
The most promising compounds (hits) are further refined to improve their potency, selectivity, and pharmacokinetic properties.
Hit-to-Lead Optimization
It is a critical phase in the process of developing a new drug. It involves extensive testing and evaluation of the compound to ensure its safety and efficacy before it can be tested in humans.
Pre-Clinical Research
“In living”
Experiments are performed on living organisms, such as animals or humans.
Examples: Testing a new drug on rats to assess its efficacy and safety.
In Vivo
“In glass”
Experiments are performed outside of a living organism, often in a laboratory setting, using artificial conditions.
Examples: Culturing cells in a petri dish to study their behavior.
In Vitro Testing
In Vivo Testing
Toxicity studies
Pharmacologic studies
In Vitro Testing Studies
Cell-Based Assays
Biochemical Assays
The application for clinical testing in humans, which is submitted to the FDA.
Investigational New Drug (IND) Application
Identifies unexpected side effects or adverse events that may not have been detected in clinical trials.
Post-Market Surveillance
Ensures that the drug’s labeling accurately reflects its benefits and risks.
Labeling Updates
Explores the drug’s effectiveness in different patient populations or for new indications.
Efficacy Assessment
