FDA Exam #1 with Complete Solutions

Define CFLADMER - ANSWER-Chemistry Formulation (pharmaceutics) Liberation (biopharmaceutics) Absorption (ADME=pharmacokinetics) Distribution Metabolism Excretion Response (pharmacodynamics) Metabolism and Excretion together are known as.. - ANSWER-Elimination Distribution, Metabolism, and Excretion are known as.. - ANSWER-Disposition Define: dissolution - ANSWER-the RATE at which a drug dissolves What your body does to the drug is known as: - ANSWER-pharmacokinetics What the drug does to your body is known as: - ANSWER-pharmacodynamics Critical determinants of the in-vivo performance, safety, and efficacy of the drugs are... (3) - ANSWER--physicochemical characteristics of the API -dosage form -route of admin T or F: Both the Pharmacist and Pharmaceutical scientist must understand these complex relationships to comprehend proper use and development of pharmaceuticals - ANSWER-True List the sequence of events that precede elicitation of a drug's therapeutic effect - ANSWER--drug in dosage form taken by pt -drug release and dissolution -(a fraction absorbed) -drug in systemic circulation-> excretion/metabolism -drug in tissues/@ recept -> pharmacological effect What is the science that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which it is given, the route of admin on the rate and extent of systematic drug absorption? - ANSWER-Biopharmaceutics Define "bioavailability" - ANSWER-The rate and extent of drug absorption Define pharmaceutics - ANSWER-refers to the study of technological and fundamental aspects related to the formulation and fabrication of dosage forms Define biopharmaceutics - ANSWER-studies physiological and dosage form factors affecting the release and subsequent absorption of drugs from drug delivery systems Biopharmaceutics study allows for the rational design of drug products based on what 6 factors? - ANSWER--physical and chemical prop of drug -the route of admin, including anatomical and physiological nature of the application site -desired pharmacodynamic effect -toxicological prop of drug -safety of excipients -effect of excipients and dosage form on drug delivery What is an "in-vitro" study? - ANSWER-procedures employing test apparatus and equipment without involving lab animals or humans What is an "in-vivo" study? - ANSWER-more complex studies, involving human subjects or lab animals What must in-vivo and in-vitro studies be able to assess? - ANSWER-Must be able to assess the impact of the physicochemical properties of the drug, drug stability, and large-scale production of the drug and drug product ON THE BIOLOGICAL PERFORMANCE OF THE DRUG What is pharmacokinetics (PK)? - ANSWER-the science of the kinetics of ADME; i.e. the fate of the drug in the body T or F: Characterization of drug disposition (DME) is an important prerequisite for determination or modification of dosing regimes for patients - ANSWER-True Define "clinical PK" - ANSWER--application of PK methods the drug therapy -multidisciplinary approach to individually optimized dosing strategies based on the pt's disease state and patient-specific consideration Define "pharmacodynamics" (PD) - ANSWER--relationship between the drug concentration at the site of action (receptor) and pharmacological response -i.e. fate of body due to drug action responses What 2 terms relate to the application of PK principles to the design, conduct, and interpretation of drug safety evaluation and used in validating dose related exposure in animals? - ANSWER--Toxicokinetics (TK) -> TK data can be extrapolated in humans -Clinical toxicology T or F: PK helps with compliance - ANSWER-True