NAPSR CNPR CHAPTER 12 Biopharmaceutical
Drug Development Correct answers latest
update
small molecule drugs
pharmaceuticals; new chemical entities (NCE's) that are produced in manufacturing plants using
techniques based on chemical reactions to reactants.
large molecule drugs
biopharmaceuticals; mainly protein based and resemble natural biological compounds found in the
human body. Manufactured in biological systems such as living cells. these resemble the body's
naturally occurring proteins, usually more potent than any other disease treatments.
3 uses biopharmaceuticals are developed for
prophylactic (preventative) therapeutic (antibodies) replacement therapy (hormones; growth factors)
biologics
a biological product subject to licensure under the Public Health Service Act that is applicable to the
prevention, treatment, or cure of disease or injuries to humans. Vaccines, antibodies, cytokines,
hormones, gene therapy, stem cells
vaccines
an antigen that has been treated to stimulate the immune system and cause antibodies to be
secreted to react against the foreign antigen.
pathogen
include mainly viruses, bacteria, parasites and fungi
virulent part
the part of a pathogen that causes disease
traditional vaccine preparation
3 ways: attenuated vaccines, killed or inactivated vaccines, toxoids
passaging
growing the pathogen in species other than the natural host
attenuated vaccine advantages
less expensive preparation, one dose sufficient, attract the desired immunological response
attenuated vaccine disadvantages
potentially revert to virtulence, limited shelf life
killed or inactivated vaccines
Drug Development Correct answers latest
update
small molecule drugs
pharmaceuticals; new chemical entities (NCE's) that are produced in manufacturing plants using
techniques based on chemical reactions to reactants.
large molecule drugs
biopharmaceuticals; mainly protein based and resemble natural biological compounds found in the
human body. Manufactured in biological systems such as living cells. these resemble the body's
naturally occurring proteins, usually more potent than any other disease treatments.
3 uses biopharmaceuticals are developed for
prophylactic (preventative) therapeutic (antibodies) replacement therapy (hormones; growth factors)
biologics
a biological product subject to licensure under the Public Health Service Act that is applicable to the
prevention, treatment, or cure of disease or injuries to humans. Vaccines, antibodies, cytokines,
hormones, gene therapy, stem cells
vaccines
an antigen that has been treated to stimulate the immune system and cause antibodies to be
secreted to react against the foreign antigen.
pathogen
include mainly viruses, bacteria, parasites and fungi
virulent part
the part of a pathogen that causes disease
traditional vaccine preparation
3 ways: attenuated vaccines, killed or inactivated vaccines, toxoids
passaging
growing the pathogen in species other than the natural host
attenuated vaccine advantages
less expensive preparation, one dose sufficient, attract the desired immunological response
attenuated vaccine disadvantages
potentially revert to virtulence, limited shelf life
killed or inactivated vaccines
