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PHCY 514 Class 8 Biologics and Biosimilars questions with correct answers
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PHCY 514 Class 8 Biologics and Biosimilars questions with correct answers
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PHCY 514 Class 8 Biologics and Biosimilars questionswith correct answers
What are biologics? Correct Answer--A virus, therapeutic serum, toxin,
antitoxin, or analogous product applicable to the prevention, treatment,
or cure of diseases or injuries of man
-Derived from living sources: cultures of bacteria or viruses. Human or
animal cells, tissue, organs
-Biological products must meet the definition of either a drug of device
as defined by the federal food, drug, and cosmetic act
What is the difference in size between small molecule drugs and
biologics? Correct Answer--Small molecule drugs: small, low molecular
weight
-Biologics: large, high molecular weight
What is the difference in structure between small molecule drugs and
biologics? Correct Answer--Small molecule drugs: Simple, well-defined
-Biologics: Complex, heterogeneous
What is the difference in manufacturing between small molecule drugs
and biologics? Correct Answer--Small molecule drugs: reproducible
chemical reactions, identical copies generated
-Biologics: living cells or organisms, impossible to make identical
copies
, What is the difference in characterization between small molecule drugs
and biologics? Correct Answer--Small molecule drugs: completely
characterized
-Biologics: Cannot fully characterize molecular composition
What is the difference in stability between small molecule drugs and
biologics? Correct Answer--Small molecule drugs: stable
-Biologics: Unstable, highly sensitive to external factors
What is the difference in immunogenicity between small molecule drugs
and biologics? Correct Answer--Small molecule drugs: relatively non-
immunogenic
-Biologics: Immunogenic
What is a small molecule drug? Correct Answer--chemistry-based
-bench-top preparation
-very reliable in product type/quality
What is a biologic therapy? Correct Answer--biology-based preparation
-Cloning, cell culture, protein isolation
-Work done in sterile cell culture rooms
What are the two branches that biologics are approved through the
FDA? Correct Answer--Center for biologic evaluation and research
(CBER)
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