CNPR, NAPSR Exam

• Therapeutic→ antibodies • Replacement therapy→ hormones, growth factors Biologics - 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 - • 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 - Attenuated Vaccines Killed or Inactivated Vaccines Toxoids