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NAPSR CNPR CHAPTER 12 Biopharmaceutical Drug Development 2023/2024 already graded A+
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NAPSR CNPR CHAPTER 12 Biopharmaceutical Drug Development 2023/2024 already graded A+
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NAPSR CNPR CHAPTER 12Biopharmaceutical Drug Development
small molecule drugs - ANSpharmaceuticals; new chemical entities (NCE's) that are produced
in manufacturing plants using techniques based on chemical reactions to reactants.
large molecule drugs - ANSbiopharmaceuticals; 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 - ANSprophylactic (preventative) therapeutic
(antibodies) replacement therapy (hormones; growth factors)
biologics - ANSa 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 - ANSan antigen that has been treated to stimulate the immune system and cause
antibodies to be secreted to react against the foreign antigen.
pathogen - ANSinclude mainly viruses, bacteria, parasites and fungi
virulent part - ANSthe part of a pathogen that causes disease
traditional vaccine preparation - ANS3 ways: attenuated vaccines, killed or inactivated vaccines,
toxoids
passaging - ANSgrowing the pathogen in species other than the natural host
attenuated vaccine advantages - ANSless expensive preparation, one dose sufficient, attract the
desired immunological response
attenuated vaccine disadvantages - ANSpotentially revert to virtulence, limited shelf life
killed or inactivated vaccines - ANSchemical or temperature treatments are normally used to kill
or inactivate a pathogen. formaldehyde, phenol, acetone or irradiation.
advantages of inactivated vaccines - ANSnon-reversal to virtulance, stable shelf life
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