Key Fields & Roles
What does target identification do?
Target identification involves pinpointing molecules or biological pathways relevant to a disease, often through genetic, biochemical, or computational approaches.
What is a “lead compound”?
An initial compound identified as a potential drug candidate for further optimization.
The acronym "FDA" stands for this.
The Food and Drug Administration
This scientific discipline is responsible for designing and optimizing chemical compounds for drug development.
Medicinal Chemistry
What is an assay?
A scientific test used to measure and analyze substances or biological functions.
What does GLP stand for?
Good Laboratory Practice
This process involves selecting the most promising drug candidate for further development.
Preclinical Candidate Selection
What does DMPK stand for?
Drug Metabolism and Pharmacokinetics; it helps predict how a drug is absorbed, distributed, and metabolized in the body.
What application must be approved before a drug moves from preclinical to clinical trials?
Investigational New Drug (IND) application
In your own words, what does toxicology do?
Focuses on assessing a substance’s potential harm before human exposure.
What is the difference between pharmacokinetics (PK) and pharmacodynamics (PD)?
PK studies how the body affects the drug (absorption, distribution, metabolism), while PD studies how the drug affects the body.
This form lists any violations, deficiencies, or concerns the FDA found during the inspection.
Form 483 (officially called an FDA Form 483: Inspectional Observations).
What is the primary goal of pre-formulations?
To assess the compound’s characteristics and identify the best way for it to remain stable and compatible with various formulation approaches.
This term describes the study of how a drug affects the body at different concentrations.
Pharmacodynamics (PD)
Name two regulatory authorities outside of the FDA (regulatory bodies in different countries).
EMA, Health Canada, MHRA, PMDA, MOHAP, etc...