Determining Bioequivalency in
Similar Bipharmaceuticals

Post Test
A score of 70% must be achieved to receive continuing education credits.
 
1. Generic drugs are:
a. Widely prescribed, well accepted by the public as safe and effective
b. Generally viewed as a clinical and economic success
c. Almost universally preferred by managed care organizations
d. All of the above
2. The majority of the current “generic” drugs are:
 a. Molecularly small
 b. Chemically synthesized compounds
 c. Oral formulations, and pharmacologically targeting one receptor or body site
 d. All of the above
3. The Drug Price Competition and Patent Term Restoration Act of 1984 allowed testing before the brand-name’s patent expires.
 True
 False
4. Why is “Generic Biological” considered an inappropriate term?
 a. Implies an exact copy of the original product, with the exact pharmaceutical actions
 b. The physiologic and clinical properties are highly dependent upon the method of productions
 c. Can alter the ratio of impurities
 d. All of the above
5. The majority of biopharmaceutical manufactures do not patent the production process but rather the biological compound itself.
   True
   False
6. Production changes:
 a. Can alter the ratio of impurities
 b. Can alter the composition of production related substances, especially the creation of proteins
 c. Can ultimately alter overall clinical effects
 d. All of the above
7 Botulinum neurotoxin was approved by the FDA in:
 a. 1980
 b. 1985
 c. 1989
 d. 1990
8 Clostridium botulinum produces what serologically distinct neurotoxins?
 a. A, B, C2, D, F, G, H
 b. A, B, C1, D, E, F, G
 c. A1, B2, C3, D4, E5, F6, G6
 d. B, C, D, E, F, G, H
9 All toxins produce temporary chemical denervation and relaxation of striated muscle.
   True
   False

 

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