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Drug Administration Routes
intravenous, oral, buccal, sublingual, rectal, subcutaneous, transdermal, topical, inhaled, and intramuscular.
Bioavailability
The proportion of a drug that enters systemic circulation after administration
drug factors affecting absorption
molecular size and lipid solubility
patient factors affecting drug absorption
surface area and blood flow
Drug Absorption Mechanisms
passive diffusion, carrier-mediated transport, pore-mediated transport and pinocytosis
Solid dosage forms
Taken orally. Require disintegration and dissolution for absorption
absorption of liquid forms
rapid
modified release tablets
release drug slowly over time
immediate-release tablets
break down in around 30 minutes
Preclinical Testing
Extensive testing in cell culture and animals to predict/measure pharmacokinetic properties
Investigational New Drug (IND)
Covers preclinical studies, manufacturing, clinical study protocols, and investigational plan for clinical development.
IND Pharmacology Section
Preclinical animal studies, pharmacokinetics, justification for human testing, in vitro models, and in silico models predicting pharmacokinetics in diverse patients.
Phase I IND
concise pharmacology section focused on distribution
toxicology
qualifications of individuals suggesting human trials