Regulation
This is what FDA stands for.
What is Food and Drug Administration?
Design and Discovery is this number step in the drug development process.
What is Step 1?
This is the phase of clinical trial that typically has the most participants.
What is Phase 4?
This is the process of regularly checking and testing a drug or substance during manufacturing. It is used to determine purity and standard composition.
What is Quality Control?
Put these in order: Manufacturing, Preclinical, Clinical, Research and Discovery, FDA Review
What is (1) Research and Discovery, (2) Preclinical, (3) Clinical, (4) FDA Review, (5) Manufacturing?
What is the FDA?
During this step researchers determine how a drug is metabolized, absorbed, and used in the body.
What is Step 1 - Design and Development?
Phase 1 of a clinical trial is typically designed to confirm how the treament works and the best ___.
What is dose (or dosage)?
This is the process of making sure all documentation is complete and all regulations are being followed.
What is Quality Assurance?
This is three things that must be included in the New Drug Application (NDA) to the FDA.
What is safety, dosage, preclinical data, clinical trial data, effectiveness, side effects?
In the sample regulation code "21 CFR 211.67(a)", 21 is the title, 211 is the part, 67 is the section, and (a) is the _____.
What is the paragraph or subsection?
These are the two types of preclinical research.
What are in vitro and in vivo?
Testing for the efficacy of a drug or treatment on a few hundred participants with the illness happens during this phase.
What is Phase 2?
This job involves research and creation of new drugs and treatments.
What is pharmaceutical scientist, biochemist?
This is what cGMP stands for.
What is Current Good Manufacturing Practices?
The Code of Federal Regulations governs agencies including the FDA and this agency abbreviated USDA.
What is the US Dept of Agriculture?
This must be determined during preclinical research before beginning clinical trials.
What is dosage and toxicity?
What is people/humans?
This job creates processes to enable the large scale manufacture of materials.
What is systems engineer?
This is what IND stands for in the IND application to the FDA.
What is investigational new drug?
After the clinical step, this (abbreviation NDA) is submitted to the FDA.
What is a New Drug Application?
This is the step number for FDA review.
What is Step 4? (after research, preclinical, clinical)
This phase of clinical trials consists of a larger group and lasts around 1-3 years to check for side effects and drug efficacy.
What is Phase 3?
This is the group that reviews applications for new clinical trials, abbreviated the IRB.
What is the Institutional Review Board?
GLP stands for this
What is Good Laboratory Practices?