What decreases water solubility? - Increasing # of C atoms in a molecule and increased molecular
weight
Clinical Phase III - Studies benefit/risk relationship of drug, less common/longer term side effects,
and labeling information on a very large group of patients
Active Pharmaceutical Ingredie...
DOSAGE FORMS EXAM 3 - MCPHS
What decreases water solubility? - Increasing # of C atoms in a molecule and increased molecular
weight
Clinical Phase III - Studies benefit/risk relationship of drug, less common/longer term side effects,
and labeling information on a very large group of patients
Active Pharmaceutical Ingredient - Any component that is intended to cause pharmacologic
activity or other direct drug effects
Pharmaceutics - General area of study concerned with the formulation, manufacture, stability and
effectiveness of pharmaceutical dosage forms
Drug - any agent intended for use in the diagnosis, mitigation, treatment, cure or prevention of
disease in humans or other animals
Broad steps of new drug development - 1) Drug Discovery
2) Animal Studies
3) Clinical Tests
4) Commercialization
In silico screening - Biological experimentation performed by a computer
Drug discovery methods - 1) Screening natural compounds
2) Screening corporate compounds
3) In silico screening
4) Rational drug design
5) Combinatorial chemistry
, Combinatorial Chemistry - Preparation of a large number of different compounds at the same
time
ADMET - Absorption
Distribution
Metabolism
Excretion
Toxicity
Absorption (testing) - To see that the drug passes GI track into blood stream
Distribution (testing) - To see that the the drug gets to target tissue
Metabolism (testing) - To see that the drug is not readily metabolized
Excretion (testing) - To see that the drug is not readily secreted
Toxicity (testing) - To see that the drug is not toxic to other cells or tissue
Biologic Pre-clinical Tests - Pharmacology, Drug metabolism and toxicology experiments
Preformulation Studies - 1) Drug solubility
2) Partition coefficient
3) Dissolution rate
4) Physical form
5) Stability
Clinical Phase I - Study's absorption/metabolism, effects on organs and tissue and side effects on
~20-100 healthy volunteers
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