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Introduction to Pharmacology: Drug Regulation and Approval Introduction to Pharmacology: Drug Regulation and Approval

Introduction to Pharmacology: Drug Regulation and Approval - PowerPoint Presentation

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Introduction to Pharmacology: Drug Regulation and Approval - PPT Presentation

Chapter 1 John Paul Joson MSN CNS OBJECTIVES What is it History Classification of Therapeutic Agents as Drugs Biologics Complementary and Alternative therapies Therapeutic and Pharmacologic Class ID: 737075

act drug health therapeutic drug act therapeutic health trade generic chemical fda biologics food pharmaceutical quality pharmacological medicine human

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Slide1

Introduction to Pharmacology: Drug Regulation and ApprovalChapter 1

John Paul Joson MSN CNSSlide2

OBJECTIVES

What is it?

History

Classification of Therapeutic Agents as :

Drugs

Biologics

Complementary and Alternative therapies

Therapeutic and Pharmacologic Class

Chemical vs Generic vs Trade Names

Prescription vs OTCSlide3

What is it? . . . PharmacologyPharmakon = ____________________

Logos = ________________________

Application of products to relieve human suffering

Focus on patient and to improve quality of lifeSlide4

PharmacologyThe study of medicine

Drug vs. Medicine

Therapeutic

Adverse

Factors Affecting Medication Doses & Responses

Age

(

Peds

, Adults

, Geriatrics)

Sex

Body mass

Health status

GeneticsSlide5

Drug Regulations and Standards

1820

Group of MDs established U.S. Pharmacopeia

(drug recipes)

1852

American Pharmaceutical Association, established National Formulary

pharmaceutical ingredients

1862

Federal Bureau

of Chemistry →Food and Drug Administration Act (FDA)

1902

Biologics

Control Act –quality of serums and other blood related products

1906

Pur

e Food and Drug Act –labeling of medicines, followed in 1912 ensure no false labels

1938

Food, Drug,

and Cosmetic Act –drugs must be tested via submission of New Drug Application to FDA prior to marketing

1986

Childhood Vaccine Act

1988

FDA →U.S. Department of

Health and Human Services

1994

Dietary Supplement

Health and Education ActSlide6

Pharmacology Classification of TherapeuticsDrug =

Desirable vs. Undesirable

Medication =

Biologics

Complementary & AlternativesSlide7

Therapeutic vs Pharmacological Class

Therapeutic = What is used for ?

Anticoagulant

Antihyperlipidemic

Antihypertensive

Antidysrhythmic

Antianginal

Pharmacological = What does it do to the body?

Diuretic

Calcium channel blocker

Angiotensin converting enzyme

VasodilatorSlide8

Chemical vs Generic vs Trade

Name

Chemical Name = International Union of Pure and Applied

ChemistryN

-acetyl-p-aminophenol

2-(4-isobutylphenyl) propanoic acid

Generic Name = U.S. Adopted Name Council = usually only one name

Acetaminophen

Ibuprofen

Trade = What everybody knows it as = many names

Tylenol, A-

mol

,

Acimol

, Activate

Advil, Motrin,

arthrofenSlide9

PharmacologyPrescription

Received written order from person with legal authority to write such a prescription

Over the counter (OTC)

Do not require physician’s order