Pharmacology for the Health Sciences

1. Pharmacology for the Health Sciences Lecture 3 Dr. Steven I. Dworkin

2. How are Drugs Named? • Chemical Name • Specifies chemical structure • Pre patent or release name • Typically drug company letters and numbers • Generic Name • Nonproprietary name (each drug has only one generic name) • Brand or Trade Name • Market name for a particular company • Common or Street Name • Users name Dr. Steven I. Dworkin

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4. Rose ibuprofen (ī'byūprō'fən) , nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. Along with naproxen and ketoprofen, ibuprofen belongs to the propionic acid class of NSAIDs. It was first made available in 1967. Like other NSAIDs, it acts by inhibiting the body's production of prostaglandins. Available over the counter in a variety of preparations (e.g., Advil, Motrin, Nuprin), it is commonly used to treat rheumatoid arthritis, gout, and painful menstruation. Side effects include rash, alteration of platelet function and bleeding, and intestinal upset, which can lead to gastritis. Like other NSAIDS, it appears to have no potential for abuse or physical dependence. It should not be used by those who are allergic to aspirin. Dr. Steven I. Dworkin

5. Drug Resources Dr. Steven I. Dworkin

6. Classification of Drugs • Grouping by chemical structure. Dr. Steven I. Dworkin

7. Classification of Drugs • Mechanism of action • Serotonin uptake inhibitors • antidepressants • beta blockers • Anti-hypertensives • H2 blockers • Anti-histamines Dr. Steven I. Dworkin

8. Drug Classification • Therapeutic Categories and Subcategories Dr. Steven I. Dworkin

9. Drug Classification Dr. Steven I. Dworkin

10. The Feds Dr. Steven I. Dworkin

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14. Pre Clinical Trials • In vitro studies • In vivo studies • Use of standard animal models • Efficacy • Potency • Safety • LD determination • ED determinations • Therapeutic Ratio • Abuse Potential or Liability • Drug self-administration Dr. Steven I. Dworkin

15. Clinical Trials • Introduction • Before a pharmaceutical company can initiate testing in humans, it must conduct extensive preclinical or laboratory research. • Preclinical research typically involves years of experiments in animal and human cells. The compounds are also extensively tested in animals. • 100-300k compounds screens 100-300 compounds 1 or 2 lead compounds • Pharmaceutical company provides selected data to the Food and Drug Administration (FDA) with a requesting approval to begin testing the drug in humans. • This is called an Investigational New Drug application (IND). • Typically this is when the clock starts clicking and the PC has the next 11 years of exclusive patent rights. Dr. Steven I. Dworkin

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17. Issues • The New Drug War (non-US markets) • Involvement of Pharmaceutical Companies • Involvement of Interest Groups • Role of advisory panel • Role of FDA officials • Publication and disclosure of negative findings • When things go wrong? • Cox-2 inhibitors • Media • Steroids • Alternative Medications Dr. Steven I. Dworkin

18. Questions • Why are drugs categorized? • What are the major differences between name brand and generics drugs? • Approximately how many drugs are tested for every drug that is approved ? • What federal agency is responsible for determining the safety and efficacy of new pharmaceuticals? • What federal agency is responsible for enforcing the regulations for scheduled compounds • What are the basic differences between OTC and prescription drugs? • Under what conditions can a schedule I drug be prescribed for a patient. • Name 2 Schedule II and 3 Schedule III compounds, what is one major difference between these compounds (difference of Schedule II compared to Schedule III) ? • Who is responsible for the appropriate use of a compound? Dr. Steven I. Dworkin