Socra Exam Prep Exam Questions and
Answers 100% Solved | Rated A+
Laws - passed by national legislative bodies; establish authority of
national regulatory body
Regulations - Passed by regulatory authorities; controls how medical
products are investigated and approved; have effect of law
guida...
ingredient); test various formulations to optimize the drug product; stability
testing in packaging planned to be used for clinical trials and marketed
product
Excipients - ✔✔inactive substances used as a carrier for the active
ingredients of a medication
non/pre-clinical activities - ✔✔drug discovery and development of dosage
Safety Pharmacology - ✔✔studies that investigate the potential undesirable
pharmacodynamics effects of a substance on physiological functions in
relation to exposure in therapeutic range and above
Animal studies - ✔✔establish general safety in multiple species; summarize
toxicities observed; determine safety margins between the planned human
dose range and toxic effects on animals; optimize the dose range,
formulation and frequency of administration
Single dose toxicity - ✔✔studies in multiple species to select doses for
repeated dose studies; look for AEs/SAEs
repeated dose toxicity - ✔✔studies to assess toxicity after multiple
administrations-results used to determine doses used for chronic
administration; look for AEs/SAEs
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