NAPSR CNPR CHAPTER 12 Biopharmaceutical Drug Development Questions with Correct Answers

Small molecule drugs Correct Answer pharmaceuticals; new chemical entities (NCE's) that are produced in manufacturing plants using techniques based on chemical reactions to reactants. Large molecule drugs Correct Answer biopharmaceuticals; mainly protein based and resemble natural biological compounds found in the human body. Manufactured in biological systems such as living cells. These resemble the body's naturally occurring proteins, usually more potent than any other disease treatments. 3 uses biopharmaceuticals are developed for Correct Answer prophylactic (preventative) therapeutic (antibodies) replacement therapy (hormones; growth factors) Biologics Correct Answer a biological product subject to licensure under the Public Health Service Act that is applicable to the prevention, treatment, or cure of disease or injuries to humans. Vaccines, antibodies, cytokines, hormones, gene therapy, stem cells Vaccines Correct Answer an antigen that has been treated to stimulate the immune system and cause antibodies to be secreted to react against the foreign antigen. Pathogen Correct Answer include mainly viruses, bacteria, parasites and fungi Virulent part Correct Answer the part of a pathogen that causes disease Traditional vaccine preparation Correct Answer 3 ways: attenuated vaccines, killed or inactivated vaccines, toxoids Passaging Correct Answer growing the pathogen in species other than the natural host Attenuated vaccine advantages Correct Answer less expensive preparation, one dose sufficient, attract the desired immunological response