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PHARMACOLOGY

1st year- 1st sem PRELIM

What is Pharmacology? Study of the biological effects of chemicals (drugs) on living organisms.
Meaning of Pharmakon? Drug, medicine, remedy, poison, spell, or charm.
Pharmacologist Discovers and develops new drugs and studies their effects and mechanisms.
Pharmacist Dispenses medications and teaches patients their safe and effective use.
Branch of pharmacology that uses drugs to treat, prevent, and diagnose disease. Pharmacotherapeutics / Clinical Pharmacology
Two focuses of Clinical Pharmacology Drug → Body = Effects of the drug on the body. Body → Drug = How the body responds to the drug.
5 Nurse's Responsibilities in Drug Therapy Administer drugs safely. Assess drug effects. Make drug regimen more tolerable. Teach patients about medications. Monitor the care plan to prevent medication errors.
Why administer drugs safely? Prevent medication errors and ensure the correct drug, route, and time.
Two major sources of drugs Natural Synthetic
Four Natural Sources Plants Animals Mineral/Earth Microbiological
Active compounds are extracted from leaves, flowers, seeds, roots, or bark. Plant drugs
Mnemonic for DOH-approved herbal medicines SANTA LUBBY
Diuretic; kidney stones and urinary problems. Sambong
Antifungal; ringworm and athlete's foot. Akapulko
Deworming; intestinal worms. Niyog-niyogan
Diarrhea, stomachache, cramps, mouthwash. Tsaang Gubat
Helps lower blood sugar. Ampalaya
Cough, colds, asthma, mild fever; loosens phlegm. Lagundi
Lowers uric acid; gout and arthritis. Ulasimang Bato
Helps lower blood pressure and cholesterol. Bawang
Antiseptic for wounds; helps diarrhea. Bayabas
Natural pain reliever. Yerba Buena
Drugs extracted from animal tissues, organs, or secretions. Examples: Insulin, Heparin, Cod liver oil. Animal sources of drugs
Drugs from naturally occurring inorganic substances. Examples: Iron, Magnesium, Lithium, Iodine. Mineral/Earth sources
Drugs produced by fungi and bacteria. Examples: Penicillin and Streptomycin. Microbiological sources
Semi-synthetic drugs Natural compounds chemically modified to improve potency, reduce side effects, enhance stability, alter solubility, or improve absorption. Examples: Heroin, Ampicillin, Aspirin.
Synthetic drugs Created entirely in laboratories from chemical building blocks. Examples: Paracetamol and Methamphetamine.
Purpose of FDA drug evaluation Ensures drugs are safe and reliable before public marketing.
Stages of Drug Development Preclinical Phase I Phase II Phase III Phase IV
Where are preclinical trials done? Cell cultures (in vitro) and animal models (in vivo).
Goals of Preclinical Trials Determine toxicity. Study absorption and excretion. Check if drug works against disease.
IND Investigational New Drug application submitted before human testing.
Phase I participants 20–100 healthy volunteers (sometimes terminally ill patients).
Goals of Phase I Evaluate safety. Determine maximum safe dose. Identify early side effects. Study pharmacokinetics.
Phase I success rate About 70% proceed to Phase II.
Phase II participants 100–300 patients with the target disease.
Goals of Phase II Determine efficacy. Find optimal therapeutic dose. Continue safety monitoring.
Double-blind study Neither the patient nor the doctor knows who receives the drug, placebo, or standard treatment.
Phase II success rate About 33% proceed to Phase III.
Goals of Phase III Confirm efficacy. Detect rare side effects. Compare with standard treatment/placebo. Collect safety and effectiveness data.
Phase III success rate About 25–30% of drugs entering Phase I reach the end of Phase III.
Brand/Trade Name Name given by the pharmaceutical company.
Generic Name Original name assigned during approval.
Chemical Name Name based on the drug's chemical structure.
Drug Lag Delay between a drug's discovery and approval or between approval in one country and another.
Fast Track FDA process that speeds development and review of drugs for serious conditions with unmet medical needs.
Benefits of Fast Track Frequent FDA communication. Rolling review of application.
When does Phase IV begin? After FDA approval and marketing.
Goal of Phase IV Detect rare or long-term adverse effects under real-world conditions.
Possible Phase IV actions if safety issues occur Black Box Warning Additional safety restrictions Removal from the market
Created by: user-2046416
 

 



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