Drug Dev. & approval process (FINAL) Flashcards
What is pharmaceutics?
The art, science, and technology of dosage form design (preparing and dispensing drugs).
What are the physiochemical properties of a drug?
stability, ionization, water/lipid solubility, hydrolysis, oxidation, racemization, etc.
What are the biological properties of a drug?
absorption, transportation, biotransformation, etc.
Name 3 common dosage forms.
capsule, tablet, solution.
Why are drugs expensive?
takes 10-15 years to develop one new medicine, costing $800 million to $1 billion.
What agency is responsible for drug approval in the U.S.?
FDA.
What is the role of the Center for Drug Evaluation and Research (CDER)?
approves drugs based on safety and effectiveness.
What is a New Chemical Entity (NCE)?
a drug that has never been approved for use.
What is the IND application?
investigational new drug application submitted for FDA review before clinical trials.
How long does preclinical research and development typically take?
approximately 3-6 years.
What happens during Phase I clinical trials?
assessing safety in 20-100 healthy volunteers.
What us the primary goal of Phase II clinical trials?
to evaluate effectiveness in several hundred patients.
How many patients are involved in Phase III clinical trials?
several hundred to several thousand patients.
What is the purpose of a New Drug Application (NDA)?
to gain permission to market the drug product in the U.S.
What is Phase IV study?
Post-marketing studies revealing additional side effects and drug interactions.
Why are dosage forms important?
patients take dosage forms, not drugs; they ensure safe and accurate delivery.
What are the main routes of administration?
oral, parenteral, topical, transdermal, ocular, etc
Classify dosage forms based on release rate?
fast action, conventional, sustained, pulsatile.
Name a solid dosage form.
tablets.
Name a liquid dosage form.
syrups.
What is the usual dose and onset of action for sublingual nitroglycerin?
0.3-0.8 mg; onset: 2-5 mins.
What is the peak action time for oral nitroglycerin?
45-120 mins.
What is the duration of action for transdermal nitroglycerin patches?
Up to 24 hrs.
What are the primary dosage forms for parenteral administration?
solutions, suspensions.
What types of formulations are used for ocular administration?
solutions, sprays, ointments.
What is the FDA’s response time for an IND application?
30 days.
What are the stages of preclinical research?
Pre-discovery, discovery, preclinical studies.
How many years does clinical research and development typically take?
6-7 years.
What is assessed during Phase I clinical trials?
safety and tolerability of a drug.
