NAPSRx Certification Exam Study Guide Chapter 10

What are some of the elements of Good Laboratory Practices? - 1) Personnel must have the education, training, and experience to conduct nonclinical studies 2) A quality assurance unit should be measurable 3) Materials for studies must be appropriately tested for identity, strength, purity, stability and uniformity 4) Appropriate personnel, resources, facilities, equipment, materials, and methodologies must be available 5) Studies must be conducted under specifically designed protocols with appropriate quality system established to handle data, deviations, and reporting 6) Animals must be isolated, have their health statuses checked regularly, and given the appropriate care 7) Nonclinical laboratory studies must be conducted in accordance with the protocols For most medication the greatest barrier is? - crossing the many membranes that separate the drug from its target cells What are the 4 categories pharmacokinetics is grouped into? - Absorption Distribution Metabolism and Excretion Interpatient variability can be best understood in response to drugs by examining what? - frequency distribution curve What is a frequency distribution curve? - is a geographical representation of the number of patients responding to a drug action at different doses What are the four basic transport mechanisms - Passive Diffusion, Facilitated Diffusion, Active Transport, and Pinocytosis type of transport that molecules diffuse across the membrane from high concentration to low concentration until equilibrium is reached? - Passive Diffusion What type of molecules are able to diffuse across a cell membrane? - Lipid soluble (non-polar) These types of molecules cannot penetrate cell membranes via passive diffusion? - Polar molecules this transport system uses transmembrane carries (such as proteins) to move from high concentration to low concentration until equilibrium is reached? - Facilitated diffusion this transport system requires energy to drive the drugs against the gradient from low to high concentration? - Active Transport