CNPR, NAPSR Exam (100% correct answers)

Drug Discovery correct answers • 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 correct answers 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 correct answers 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 correct answers • Prophylactic→ preventive as in vaccines • Therapeutic→ antibodies • Replacement therapy→ hormones, growth factors Biologics correct answers 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 correct answers • 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