©THEBRIGHT EXAM STUDY SOLUTIONS 8/27/2024 12:01 PM
DOSAGE FORMS EXAM 3 - MCPHS FALL
2024
Pharmaceutics - answer✔✔General area of study concerned with the formulation, manufacture,
stability and effectiveness of pharmaceutical dosage forms
Drug - answer✔✔any agent intended for use in the diagnosis, mitigation, treatment, cure or
prevention of disease in humans or other animals
Active Pharmaceutical Ingredient - answer✔✔Any component that is intended to cause
pharmacologic activity or other direct drug effects
Broad steps of new drug development - answer✔✔1) Drug Discovery
2) Animal Studies
3) Clinical Tests
4) Commercialization
In silico screening - answer✔✔Biological experimentation performed by a computer
Drug discovery methods - answer✔✔1) Screening natural compounds
2) Screening corporate compounds
3) In silico screening
4) Rational drug design
5) Combinatorial chemistry
Combinatorial Chemistry - answer✔✔Preparation of a large number of different compounds at
the same time
ADMET - answer✔✔Absorption
Distribution
Metabolism
Excretion
, ©THEBRIGHT EXAM STUDY SOLUTIONS 8/27/2024 12:01 PM
Toxicity
Absorption (testing) - answer✔✔To see that the drug passes GI track into blood stream
Distribution (testing) - answer✔✔To see that the the drug gets to target tissue
Metabolism (testing) - answer✔✔To see that the drug is not readily metabolized
Excretion (testing) - answer✔✔To see that the drug is not readily secreted
Toxicity (testing) - answer✔✔To see that the drug is not toxic to other cells or tissue
Biologic Pre-clinical Tests - answer✔✔Pharmacology, Drug metabolism and toxicology
experiments
Preformulation Studies - answer✔✔1) Drug solubility
2) Partition coefficient
3) Dissolution rate
4) Physical form
5) Stability
Clinical Phase I - answer✔✔Study's absorption/metabolism, effects on organs and tissue and
side effects on ~20-100 healthy volunteers
IND - answer✔✔Investigational New Drug Application
Clinical Phase II - answer✔✔Studies effectiveness in treatment, short-term side effects and dose
range on a large number of patients (control and treatment groups)
Clinical Phase III - answer✔✔Studies benefit/risk relationship of drug, less common/longer term
side effects, and labeling information on a very large group of patients
NDA - answer✔✔New Drug Application
Reasons for new drug failure - answer✔✔Pharmacokinetics (39%)
Lack of efficacy (30%)
Animal toxicity (11%)
Adverse effects in man (10%)
Commercial reasons (5%)
Other (5%)
DOSAGE FORMS EXAM 3 - MCPHS FALL
2024
Pharmaceutics - answer✔✔General area of study concerned with the formulation, manufacture,
stability and effectiveness of pharmaceutical dosage forms
Drug - answer✔✔any agent intended for use in the diagnosis, mitigation, treatment, cure or
prevention of disease in humans or other animals
Active Pharmaceutical Ingredient - answer✔✔Any component that is intended to cause
pharmacologic activity or other direct drug effects
Broad steps of new drug development - answer✔✔1) Drug Discovery
2) Animal Studies
3) Clinical Tests
4) Commercialization
In silico screening - answer✔✔Biological experimentation performed by a computer
Drug discovery methods - answer✔✔1) Screening natural compounds
2) Screening corporate compounds
3) In silico screening
4) Rational drug design
5) Combinatorial chemistry
Combinatorial Chemistry - answer✔✔Preparation of a large number of different compounds at
the same time
ADMET - answer✔✔Absorption
Distribution
Metabolism
Excretion
, ©THEBRIGHT EXAM STUDY SOLUTIONS 8/27/2024 12:01 PM
Toxicity
Absorption (testing) - answer✔✔To see that the drug passes GI track into blood stream
Distribution (testing) - answer✔✔To see that the the drug gets to target tissue
Metabolism (testing) - answer✔✔To see that the drug is not readily metabolized
Excretion (testing) - answer✔✔To see that the drug is not readily secreted
Toxicity (testing) - answer✔✔To see that the drug is not toxic to other cells or tissue
Biologic Pre-clinical Tests - answer✔✔Pharmacology, Drug metabolism and toxicology
experiments
Preformulation Studies - answer✔✔1) Drug solubility
2) Partition coefficient
3) Dissolution rate
4) Physical form
5) Stability
Clinical Phase I - answer✔✔Study's absorption/metabolism, effects on organs and tissue and
side effects on ~20-100 healthy volunteers
IND - answer✔✔Investigational New Drug Application
Clinical Phase II - answer✔✔Studies effectiveness in treatment, short-term side effects and dose
range on a large number of patients (control and treatment groups)
Clinical Phase III - answer✔✔Studies benefit/risk relationship of drug, less common/longer term
side effects, and labeling information on a very large group of patients
NDA - answer✔✔New Drug Application
Reasons for new drug failure - answer✔✔Pharmacokinetics (39%)
Lack of efficacy (30%)
Animal toxicity (11%)
Adverse effects in man (10%)
Commercial reasons (5%)
Other (5%)
