DDS Exam 1 Questions With 100% Correct Answers verified by Expert

DDS Exam 1 Questions With 100% Correct Answers verified by Expert Drug Development Pipeline - answer1. Drug Discovery 2. Biological Characterization and Preformulation Studies 3. IND 4. Clinical Trials, Final Development, Long Term Toxicity 5. NDA 6. Post-Marketing Target - answerUsually receptor Hit - answerMolecule that interacts with targets Lead - answerPrototype chemical that has desired biological or pharmacological activity Candidate - answerThe lead most suitable for further investigation Biological Characterization - answer1. Drug Action 2. Drug Fate Drug Action - answer1. Pharmacodynamics 2. Toxicology 3. Carcinogen, Reproductive Tox., Mutagenicity Short Term or Acute - answerSingle-dose or short-term multi dose Subchonic - answerAt least 2 weeks Chronic - answerMust study for at least 1 year Preformulation - answerPhysical and chemical properties; also manufacturing, package, label design IND (Investigational New Drug Application) - answerIncludes all pre-clinical studies and plan for clinical trials 30 day safety review - answerAutomatic time period in which a drug cannot be given to humans before it is reviewed by the FDA FDA Drug Classification - answer1. Chemical Type 2. Therapeutic Potential Phase 1 Clinical Trial - answerPurpose: safety and dosage Healthy volunteers 1.5 years Phase 2 Clinical Trial - answerPurpose: effectiveness and short-term safety Patients with indication 2 years Phase 3 Clinical Trial - answerPurpose: confirm effectiveness and longer term safety Patient with indication 3.5 years Phase 4 Clinical Trials - answerPost-marketing to monitor drug safety and efficacy Comprehensive annual reports are REQUIRED Current Good Manufacturing Practice Standards (CGMP) - answerInspection of facilities in guidelines of FDA IND for Orphan Drugs - answerTax incentives, 7 year exclusivity, financial support Expanded Access (Compassionate Use) IND - answerPatients with life-threatening or debilitating illness where no alternative is available. Filed during Phase 1 or 2 Abbreviated NDA - answerUsed for generic approvals; omits nonclinical data except those pertaining to bioavailability Supplemental NDA - answerChanges in labeling, container, formulation, etc. Four Expedited Programs for Serious Conditions - answer1. Fast Track 2. Breakthrough Therapy 3. Accelerated Approval 4. Priority Review Fast Track - answerPotential to fill an unmet medical need Breakthrough Therapy - answerDemonstrate substantial improvement over available therapy on clinically significant endpoints (clinical data showed reduction in disease progression or reduced mortality) Accelerated Approval - answerFills an unmet medical need based on a surrogate endpoint (marker that predicts clinical benefit) Priority Review - answerSignificant improvement in safety or effectiveness when compared to standard applications Biopharmaceutics - answerStudy of the effects of physicochemical properties of the drug and the drug product, in vitro, on bioavailab