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Process of Drug Approval in the United States
Chemical isolation and IdentificationAnimal studiesInvestigational New Drug approval (phase 1, phase 2, phase 3)*New Drug Application (investigational drug)FDA new drug classification system (Chemical/pharmaceutical standing 1-6)(Therapeutic Potential A-C)*Orphan drugs
5 advantages of Aerosolized agents given by inhalation
Smaller doses*fewer side effectsrapid onsettargeted to respiratory system*Painless, safe, and convenient
What is the trade or brand name of a drug
name assigned by various companies producing the same drug
Investigational New Drug (IND) Approval
phase 1 studies: small number, healthy subjects*phase 2 studies: small number, subjects with disease*phase 3 studies: Large, multicenter studies
Sources of Drug information
1: The United States Pharmacopeia-National Formulary (USP-NF)*2: Physician's Desk Reference (PDR)*also in the Goodman & Gilman's The Pharmacological Basis of Therapeutics, eleventh edition, and Basic &Clinical Pharmacology, ninth edition
What is an Orphan Drug
drug used to treat rare disease and the company looks for no financial gain on drug
The Prescription Parts
Parts would include (Patient name, address and date)*(Rx)(inscription)(subscription)(Sig)*(name of prescriber)....there is also a spot on the prescription that lets the pharmacy know if a generic substitution is okay (saves money)
Topical vasoconstriction and decongestion; relaxation of cholinergically induced bronchoconstriction
Prevention of the onset and development of asthmatic response (mediator)...maintenance drugs.
Aqueous diffusion*Lipid diffusionCarrier-mediated transportPincytosis*Factors affecting absorption
Plasma clearance (expressed as liters or L/kg)*Maintenance dose (levels of dosing = elimination)Plasma half-life (plasma concentration of a drug to decrease by ½)*Time-plasma curves
Inhaled aerosols in pulmonary disease
Target (airway ...open it), (Secretions....clear it), (Mast cells....engulf them), (Bronchial smooth muscle of the airway....relax it)
proportion of drug available from the lung, out of the total systemically available drug. Formula: (Lung dose)/(lung dose + GI dose). *The higher the ratio the more efficient the aerosol drug delivery to the respiratory tract.....the more its gonna target receptors
Factors increasing L/T Ratio
Efficient delivery devices Inhaled drugs with high first-pass metabolism Mouth washing Use of a reservoir device
What is the first-pass effect
How much of drug going to be available after the liver metabolizes it.
What is the therapeutic index
the difference between the minimal therapeutic and the toxic concentrations of a drug
Structure-activity relations *Nature and type of drug receptors (Drug receptors)(Lipid-soluble drugs and intracellular receptor activation)(Drug-regulated ion channels)(receptors linked to G proteins)
the standard unit of volume is Liter
1 milliliter = 0.001 liter 1 kiloliter = 1000 liters
1 milliliter = 1ml 1 liter = 1l 1 kiloliter = 1kl
for reference....1 liter is a little more than 1 quart, and one teaspoon equals about 5 milliliters
the standard unit of mass is Gram
1milligram = 0.001 gram 1 kilogram = 1000 grams
1milligram - 1mg 1 kilogram = 1kg
for reference....1 gram is about the mass of a paper clip, and one kilogram is about the mass of a liter of water
When converting from smaller to larger just move the decimal point over 3 spaces to the right....
When converting from larger to smaller just move the decimal point over 3 spaces to the left...
Calculating with proportions
Convert to consistent units of measure and set up a straightforward proportion...
Original Dose Desired Dose
Per Amount Per Amount
Calculating with a Dosage Schedule
Calculate the dose needed (mg/kg) and calculate the amount of the preparation....
Original Dose (mg) Desired Dose (drug needed)
Per Amount (kg) Per Amount (solution)
Calculating Doses from Percentage-strength solutions
Types of percentage preparations
Weight to weight...(W/W...Grams per 100g of mixture)
Weight to volume...W/V....Grams per 100 ml of mixture
Volume to volume...V/V....Milliliters per 100 ml of mixture
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