NAPSRX/CNPR EXAM 2 Questions And Correct
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Drug Discovery - ANSWER>>• Unlike small molecule drugs
(pharmaceuticals), large molecule drugs (biopharmaceuticals) are
mainly protein-based
o These protein-based drugs are similar to natural biological
compounds found in human body or they're fragments that mimic
active part of natural compounds
Discovery of Pharmaceuticals - ANSWER>>commences w/ scanning
hundreds of compounds, whether w/ actual materials (irrational
approach) or virtual simulations (rational approach)
• Pharmaceuticals are new chemical entities (NCE) and are produced
(synthesized) in manufacturing plants using techniques based on
chemical reactions of reactants
Discovery of Biopharmaceuticals - ANSWER>>researchers have to
examine compounds w/in humans
o Ex. Hormones or other biological response modifiers and how they
affect biological processes
o In some cases, study pathogens such as influenza virus or bacteria to
derive vaccines
o In other cases, researchers copy these biological response modifiers
and use them as replacement therapy
,o Protein-based drugs are manufactured in biological systems, such as
living cells, producing desired protein molecules in large reaction
vessels or by extraction from animal serum
o Becoming increasingly important
• More potent and specific—more similar to proteins w/in body
therefore more effective in treating our diseases
Areas of Biopharmaceuticals - ANSWER>>• Prophylactic→ preventive
as in vaccines
• Therapeutic→ antibodies
• Replacement therapy→ hormones, growth factors
Biologics - ANSWER>>FDA definition is:
o Biological product subject to licensure under Public Health Service Act
is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, a blood
component or derivative, allergenic produce, or analogous product,
applicable to prevention, treatment or cure of diseases or injuries to
humans. Biological products include, but are not limited to, bacterial
and viral vaccines, human blood and plasma and their derivatives, and
certain products produced by biotechnology, such as interferons and
erythropoietins. Biologics encompass many different protein-based
drugs, and include blood products such as clotting factors extracted
from blood.
Vaccines - ANSWER>>• Basis of vaccination is that administering small
quantity of a vaccine (antigen that has been treated) stimulates our
immune system and causes antibodies to be secreted to react against
foreign antigen
,• Later in life, when we encounter another exposure to same antigen,
our immune system will evoke a memory response and activate
defense mechanisms by generating antibodies to combat invading
antigen
• Contains antigenic components that are obtained from or derived
from pathogen
o Include mainly viruses, bacteria, parasites and fungi
o Research has shown that part of pathogen that causes disease
(virulence) can be decoupled from protective part (immunity)
• Development focuses on means to reduce virulence factor while
retaining immunity stimulation
• Oral or parenteral
Vaccine Preparations - ANSWER>>Attenuated Vaccines
Killed or Inactivated Vaccines
Toxoids
Attenuated Vaccines - ANSWER>>• Virulence of pathogen that can be
reduced in number of ways
• By chemical treatment, by temperature adaptation, or by growing
pathogen in specified other than natural host (passaging)
• Advantages are low cost preparation, elicit desired immunological
response, and normally single dose is sufficient
• Disadvantages are potential to revert to virulence and limited shelf
life
Killed or Inactivated Vaccines - ANSWER>>• Chemical and temperature
treatment are normally used to kill or inactivate pathogen
, • Formaldehyde treatment most common method
• Other chemicals used are phenol and acetone
• Another method is to irradiate pathogen to render it inactive
• Advantages are non-reversal to virulence and relatively stable shelf
life
• Disadvantages are higher cost of production, more control is required
for production to ensure reliable processes for complete inactivation
and there is possibility of reduced immunological response due to
treatment processes so multiple booster vaccinations may be required
Toxoids - ANSWER>>• Derived from toxins secreted by pathogen
• Advantages and disadvantages similar to killed or inactivated
vaccines(advantages: non-reversal to virulence and relatively stable
shelf life; disadvantages: higher cost of production, more control is
required for production to ensure reliable processes for complete
inactivation and there is possiblity of reduced immunological response
due to treatment processes so multiple booster vaccinations may be
required)
New Vaccines - ANSWER>>• Advances in genomics, molecular biology
and recombinant technology has provided new directions for discovery,
development and manufacture of vaccines
• Current approach is minimalist strategy to decouple virulence and
immunity functions
• Aim is to use only immunity part to confer protection, so vaccine is
safe to be administered
• Approach can be divided into subunit, vector-based, DNA and peptide
vaccines
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