CNPR, NAPSR Exam Pack 2022 (ANSWERED).

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: