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Process of Drug Approval in the United States

Abbreviations and Symbols

5 advantages of Aerosolized agents given by inhalation

Smaller doses***fewer side effects****rapid onset****targeted to respiratory system***Painless, safe, and convenient

what is the generic name of a drug

the official name

What is the trade or brand name of a drug

name assigned by various companies producing the same drug

Name given by a manufacturer

Proprietor name

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

Sources of Drugs

Animal, Plant, and Mineral

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)

Devices used by RCP

SVN....MDI.....DPI

Adrenergic

Relation of bronchial smooth muscle and bronchodilation

Anticholinergic

Topical vasoconstriction and decongestion; relaxation of cholinergically induced bronchoconstriction

Mucoactive agents

Agents lower viscosity and promote clearance of secretions

Corticosteroids

Reduction of and control of airway inflammatory response

Antiasthmatic agents

Prevention of the onset and development of asthmatic response (mediator)...maintenance drugs.

Antiinfective agents

Inhibition or eradication of specific infective agents

Exogenous surfactants

Restoring normal lung compliance in newborns....keeps alveoli open

Dilation vs. constriction

Opening up vs. smaller...closing up

Enteral

(inside the gut)....Orally, Suppositories, Sublingual, and Gastric tubes

Parenteral

(injection)....Intravenous, Intramuscular, and Subcutaneous

Transdermal

(patch)...Applied to the skin

Inhalation

Inhaled into the lungs (Systemic effect) or (local effect)

Topical

(cream)...Applied directly to the skin or mucous membranes

Absorption

Aqueous diffusion***Lipid diffusion****Carrier-mediated transport****Pincytosis***Factors affecting absorption

Distribution

Volume of distribution (concentrations)(total amount of drug/to plasma concentration)

Metabolism

Site of drug biotransformation***Enzyme induction and inhibition***First-pass effect

Elimination

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)

Distribution of inhaled aerosols

Oral portion (stomach) and inhaled portion

L/T Ratio

Factors increasing L/T Ratio

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

Pharmacodynamic Phase

Synergism

Two drugs act together to create a greater effect

Additivity

Two drugs act on the same receptor for maximal effect

Potentiation

One drug can increase the effect of the other

Kilo

k 10³ 1000 thousand

Milli

m 10⁻³ 0.001 thousandth

Volume

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

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

Mass

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

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

Percentage

amount of solute that is in a solution containing 100 parts

Schedule

amount of drug that is needed, based on a patient's weight

Solute

a substance that is dissolved in a solution

Solution

Physically homogeneous mixture of two or more substances

Converting Units

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...

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

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)

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

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

Calculations

**Solutions of drugs using percentage strengths

**Solutions of drugs using percentage strengths

1. Convert to metric units and decimal expressions

2. Substitute known in the appropriate equation

3. Use grams or milliliters in the percentage equation

4. Express the answer in the units requested

2. Substitute known in the appropriate equation

3. Use grams or milliliters in the percentage equation

4. Express the answer in the units requested