Part 2 Flashcards
(61 cards)
What is the difference between USP/NF and PPI
USP is telling about individual compounds used to PRODUCE product. it is not the product itself. (ie: the compound amoxicillin)
PPI is information about the FINAL PRODUCT (the trade name. ie: amoxil)
A generic API would be shown on a….
USP/NF
What does NDA and IND stand for? Which is submitted first?
NDA= new drug application
IND= Investigational New Drug
IND is submitted first
When is an IND application submitted?
- new chemical entity discovered (API)
- Preclinical studies
THEN THE IND APPLICATION IS SUBMITTED AND REVIEWED BY THE FDA
Name 5 sources of a new chemical entity
-organic synthesis
-molecular modification
-isolation from plants
-extraction from animal tissue
-genetic engineering
Define further what “preclinical studies” means.
What happens after the preclinical studies are conducted?
preclinical studies is finding out the chemistry, physical and biological properties of the drug. ex: the pharmacology, the ADME, and the toxicology.
Preformulation
AFTER THE PRECLINICAL STUDIES ARE CONDUCTED, AN IND IS SUBMITTED AND REVIEWED BY THE FDA
PRECLINICAL STUDIES CONTINUE WHILE THE IND IS BEING REVIEWED:
-long term animal toxicity
-product formulation
-manufacturing and controls
-package and label design
When do clinical trials start being conducted?
phases 1-3 are conducted after the 30 day wait period after the IND is submitted
When is an NDA submitted?
After an IND has been approved by the FDA and phases 1-3 of clinical trials have been completed. All preclinical studies are complete
If the FDA approves an NDA, what is happening after the drug hits the market? (postmarketing)
-PHASE 4 CLINICAL STUDIES
(ie: clinical pharmacology/toxicology)
-adverse reaction reporting
-product defect reporting
-product line extension
WHERE are preclinical studies taking place?
in the setting of the company who discovered the new chemical entity (API)
When are issues like solubility of the API handled?
during preclinical studies
how long does the FDA take to review an IND? What happens if the FDA rejects an IND?
30 days
if the FDA rejects it, the company has to stop phases 1-3 of the clinical trials
How long does the FDA take to review and approve an NDA?
around 11/2 years
approximately how long does a drug take to be discovered and then finally hit the market
preclinical — 61/2 years
clinical —– 7 years
NDA review —- 11/2 years
approximately 15 years
What does the term “goal drug” mean
goal drug refers to a drug that has a good ADME (absorption, distribution, metabolism, excretion), no side effects, and good solubility without any modifications.
The “goal drug” is not yet discovered
In today’s age, are more drugs discovered or modified?
modified and designed. all the drugs that were “easy” to discover have already been discovered over the years
Name some methods of drug discovery
-random screening (luck)
-non-random screening
-biologic assays (not worried abt ADME–just if goal is accomplished)
-molecular modification
-mechanism-based drug design
What is a lead compound
a chemical compound that has pharmacological/biological activity but has suboptimal structure that requires it to be modified to fit better to the target
What are prodrugs?
prodrugs are inactive substances that do NOT HAVE THERAPEUTIC EFFECT. they are not drugs.
Prodrugs become biotransformed in the body to become a drug and gets activated
Are prodrugs drugs?
NO- they become drugs once they enter the body
What is the FDA’s definition of a new drug
-new formulation
-new manufacturing method
-new combination of drugs
-new indication for use. etc
Name 3 names of a drug
-generic name
-trade name
-empirical formula; synthetic chemical name; code number
The “name brand” of a medication could also be called the…
trade name
The generic name of a drug could also be referred to as the….
nonproprietary name
