Exercises
Now you try it...
Complete the following exercises (A, B, & C) and then check your answers by clicking on the "Check Yourself" icon.
A. Determine whether or not each data element listed can commonly be found in a drug pipeline directory. Check your answers by clicking on the "Check Yourself" icon.
- Chemical name
- Chemical structure
- Therapeutic Classification Code
- Name of the scientist who first isolated the drug
- FDA filing identification
- Originating organization
- Current development status
- Pharmacological action
- Names of pharmacies dispensing the drug
Check yourself
Click the Check Yourself button above to see the answers to exercise 1-A.
B. For each data element in the list below, choose the one answer that most likely identifies what kind of drug pipeline data it is. Check your answers by clicking on the "Check Yourself" icon.
- UK-11604
(a) chemical formula
(b) lab code
(c) CAS® Registry Number
(d) pharmacology
(e) development phase - elitriptan
(a) pharmacology
(b) originating organization
(c) generic drug name
(d) lab code
(e) therapeutic classification - N8A (Antimigrane)
(a) generic drug name
(b) development phase
(c) pharmacology
(d) therapeutic classification
(e) CAS® Registry Number - Phase III
(a) chemical formula
(b) lab code
(c) development phase
(d) pharmacology
(e) therapeutic classification - Pfizer
(a) pharmacology
(b) originating organization
(c) generic drug name
(d) lab code
(e) therapeutic classification - 14322-58-1
(a) originating organization
(b) therapeutic classification
(c) chemical formula
(d) CAS® Registry Number
(e) lab code - 5 HT-1 agonist
(a) pharmacology
(b) therapeutic classification
(c) chemical formula
(d) CAS® Registry Number
(e) lab code - 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide
(a) phamacology
(b) therapeutic classification
(c) chemical formula
(d) CAS® Registry Number
(e) lab code
Check yourself
Click the Check Yourself button above to see the answers to exercise 1-B.
C. Match the drug development phase in the LIST OF DEVELOPMENT PHASES below with its correct description. Check your answers by clicking on the "Check Yourself" icon.
LIST OF DEVELOPMENT PHASES
- Discovery
- Biological Testing
- Pre-clinical/Animal Testing
- Phase I Clinical Trial
- Phase II Clinical Trial
- Phase III Clinical Trial
- Approval
- Post-Marketing
DEVELOPMENT PHASE DESCRIPTIONS
___ Studies to determine the long term adverse effects in 1,000-3,000 volunteers with the targeted disease.
___ Initial screening for potential activity, toxicity, and stability.
___ Studies on 20-80 healthy volunteers to determine safe dosage ranges, absorption, and metabolism.
___ Reports to the FDA of any adverse reactions or quality control issues. The FDA may also require Phase IV studies. Possible patent extensions, product recalls or withdrawal from market.
___ Studies to evaluate efficacy and adverse effects in 100-300 volunteers with the targeted disease.
___ Synthesis, isolation, chemical and physical characterization.
___ FDA approves a drug for marketing for interstate sales for specific dosage forms and indications.
___ Extensive series of laboratory and animal studies to evaluate safety and biological activity against the targeted disease.
Check yourself
Click the Check Yourself button above to see the answers to exercise 1-C.
When you have completed the exercises successfully, go on to the Lesson summary. If you missed more than 3 of the answers, you may want to review parts of the lesson again.
