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Dosage Forms Exam 3 - MCPHS 2024/2025: Qs And As
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Dosage Forms Exam 3 - MCPHS 2024/2025: Qs And As
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Dosage Forms Exam 3 - MCPHS 2024/2025: Qs And AsPharmaceutics Right Ans - General area of study concerned with the
formulation, manufacture, stability and effectiveness of pharmaceutical
dosage forms
Drug Right Ans - any agent intended for use in the diagnosis, mitigation,
treatment, cure or prevention of disease in humans or other animals
Active Pharmaceutical Ingredient Right Ans - Any component that is
intended to cause pharmacologic activity or other direct drug effects
Broad steps of new drug development Right Ans - 1) Drug Discovery
2) Animal Studies
3) Clinical Tests
4) Commercialization
In silico screening Right Ans - Biological experimentation performed by a
computer
Drug discovery methods Right Ans - 1) Screening natural compounds
2) Screening corporate compounds
3) In silico screening
4) Rational drug design
5) Combinatorial chemistry
Combinatorial Chemistry Right Ans - Preparation of a large number of
different compounds at the same time
ADMET Right Ans - Absorption
Distribution
Metabolism
Excretion
Toxicity
Absorption (testing) Right Ans - To see that the drug passes GI track into
blood stream
, Distribution (testing) Right Ans - To see that the the drug gets to target
tissue
Metabolism (testing) Right Ans - To see that the drug is not readily
metabolized
Excretion (testing) Right Ans - To see that the drug is not readily secreted
Toxicity (testing) Right Ans - To see that the drug is not toxic to other cells
or tissue
Biologic Pre-clinical Tests Right Ans - Pharmacology, Drug metabolism and
toxicology experiments
Preformulation Studies Right Ans - 1) Drug solubility
2) Partition coefficient
3) Dissolution rate
4) Physical form
5) Stability
Clinical Phase I Right Ans - Study's absorption/metabolism, effects on
organs and tissue and side effects on ~20-100 healthy volunteers
IND Right Ans - Investigational New Drug Application
Clinical Phase II Right Ans - Studies effectiveness in treatment, short-term
side effects and dose range on a large number of patients (control and
treatment groups)
Clinical Phase III Right Ans - Studies benefit/risk relationship of drug, less
common/longer term side effects, and labeling information on a very large
group of patients
NDA Right Ans - New Drug Application
Reasons for new drug failure Right Ans - Pharmacokinetics (39%)
Lack of efficacy (30%)
Animal toxicity (11%)
Adverse effects in man (10%)
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