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CNPR, NAPSR Exam – Qs & As - Complete Study Guide
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CNPR, NAPSR Exam – Qs & As - Complete Study Guide
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CNPR, NAPSR Exam – Qs & As - Complete Study GuideDrug Discovery Right Ans - • 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 Right Ans - 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 Right Ans - 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 Right Ans - • Prophylactic→ preventive as in
vaccines
• Therapeutic→ antibodies
• Replacement therapy→ hormones, growth factors
Biologics Right Ans - 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 Right Ans - • 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 Right Ans - Attenuated Vaccines
Killed or Inactivated Vaccines
Toxoids
Attenuated Vaccines Right Ans - • 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 Right Ans - • 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 Right Ans - • 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 Right Ans - • 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
Subunit Vaccines Right Ans - • Use only part of bacteria or virus instead of
entire pathogen
• Part is derived from outside envelope protein of pathogen
• Requires knowledge of genome sequence of pathogen by identifying open
reading frames (ORF) that potentially encode novel antigenic surface proteins
known as epitopes, which bind to antibodies
• When identified, ORFs are cloned to express protein epitopes using self-
replicating plasmids
• Binding properties of epitopes can be studied using enzyme linked
immunosorbent assay (ELISA) or fluorescent activated cell sorter (FACS)
• Leading candidates of epitopes are injected into animals to determine
whether they elicit any antibody response
o Those that work are selected and optimized to become vaccine candidates
w/ further tests before human clinical trials
, o Also working on multiple epitope subunit vaccines which can provide
different antigenic binding sites
Vector-based Vaccines Right Ans - • Viruses and bacteria are detoxified and
used as vehicles to carry vaccines
• Subunit vaccines are being delivered by carrier vehicles to elicit immune
response
• Multiple types of envelope proteins can be delivered w/ this method
• Clinical trials w/ this type of vector-based vaccines are being investigated
DNA Vaccines Right Ans - • Aka nucleic vaccines or genetic immunization
• Host (patient) is directly injected w/ selected viral genes which contain
engineered DNA sequences that code for antigens
• Hosts own cells take up these genes and express antigens which are then
presented to immune cells and activate immune response
Peptide Vaccines Right Ans - • Chemically synthesized and normally consist
of 8-24 amino acids
• Relatively small
• Aka peptidomimetic vaccines as they mimic epitopes
• Complex structures of cyclic components, branched chain or other
configurations can be built into peptide chain
• They possess conformations similar to epitopes and can be recognized by
immune cells
• An in silico vaccine design approach has been used to find potential epitopes
• Critical aspect of peptide vaccines is to produce 3D structures similar to
native epitopes of pathogen
Adjuvant Right Ans - • Vaccines formulated w/ certain substances to
enhance immune response
• Latin adjuvare→ to help
• Most common adjuvants for humans are aluminum hydroxide, aluminum
phosphate and calcium phosphate
• Others include bacteria and cholesterol
• Mineral oil emulsions normally adjuvants used in animal studies
• Adjuvant known as Freund's Complete Adjuvant consists of killed tubercle
bacilli in water-in-mineral oil emulsion
• Freund's Incomplete Adjuvant is water-in-oil emulsion
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