CNPR, NAPSR Exam Pack 2022
Drug Discovery• Unlike small molecule
drugs (pharmaceuticals), large molecule drugs
(biopharmaceuticals) are mainly protein-based o These proteinbased
drugs
are
similar
to
natural
biological
compounds
found
in
human body or they're fragments that mimic active part of
natural compounds
Discovery of Pharmaceuticalscommences 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
researchers have to examine compounds w/in humans
o Ex. Hormones or other biological response modifiers and how
Report
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 responsemodifiers 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
• Prophylactic→ preventive as in vaccines
• Therapeutic→ antibodies
• Replacement therapy→ hormones, growth factors
Biologics
FDA definition is: