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Chapter Overview

• Title: Understanding Pharmacology for Health Professionals, Sixth Edition

• Focus: Drug Testing, Drug Forms, and Drug Measurements

Learning Objectives

2.1-2.3 Drug Testing Process

• Describe chemical and animal testing as well as clinical drug trials.

• Identify key laws and federal agencies commanding drug testing and marketing.

• List various forms in which drugs are manufactured.

2.4-2.6 Drug Forms

• Describe different types of tablets (7 types) and capsules (2 types).

• Differentiate between ointments, creams, and lotions.

• Explain the variability between solutions and suspensions.

2.7-2.9 Measurement Systems

• Outline the metric system for drug measurement.

• Introduce alternative drug measurements including units, milliequivalents, percentages, and ratios.

• Engage in Chapter Review Exercises to assess mastery of topics.

Drug Testing and Legislation

Overview

• Drug testing must follow FDA guidelines before marketing.

• Testing aims to ascertain:

  • Effectiveness

  • Safety

Challenges of Drug Testing

• Considered time-consuming and expensive.

• Involves extensive processes including development, testing, manufacturing, and marketing.

• Thousands of chemicals may undergo evaluation before receiving FDA approval.

Chemical and Animal Testing

In Vitro vs. In Vivo Testing

• In Vitro: Testing in glass; involves chemical analysis in test tubes.

• In Vivo: Testing in living organisms; involves animal and subsequent human testing.

Purpose of Animal Testing

• Preceding human trials to evaluate:

  • Side effects

  • Toxicity

  • Potential addictions

  • Risks of tumors and deformities

  • Overview of pharmacodynamics

Pharmacodynamics Basics

• Half-life: Time for drug concentration to reduce by half; influenced by metabolism and excretion.

• Therapeutic Index (TI): Safety measure indicating the margin between effective and toxic doses; higher TI is more favorable.

Investigational New Drug (IND) Application

• Submission post-animal study completion to request human testing approval from FDA.

• Requires demonstration of no undue risks based on prior findings.

Clinical Drug Trials

Phases of Human Testing

• Phase I: 10-100 healthy volunteers; focus on safety and dosage.

• Phase II: 50-500 patients; evaluate therapeutic effects over approximately 2 years.

• Phase III: Hundreds or thousands of patients; Performance comparison with existing drugs.

• Phase IV: Post-marketing approval studies on different demographics and prolonged safety analyses.

Drug Manufacturing Regulations

Overview

• Regulation ensures:

  • Quality

  • Sanitation

  • Proper packaging

Generic vs. Trade Name Drugs

• Both must have identical active ingredients and dosage strengths but can differ in bioavailability.

• National Drug Code (NDC) serves as a unique identifier.

Drug Forms

Types of Pharmaceutical Forms

• Solid Forms: Tablets, capsules, films.

• Semi-Solid Forms: Ointments, creams, lotions.

• Liquid Formulations: Solutions, suspensions, syrups, sprays, tinctures.

• Powders and Other Forms: Suppositories, transdermal patches, pellets, wafers, gases.

Drug Measurements

Measurement Systems Overview

• Historical methods like the apothecary system are largely obsolete; most now rely on the metric system (milligrams, milliliters).

Other Measurement Systems

• Units: Such as for insulin.

• Milliequivalents: Particularly for electrolytes.

• Percentages: Used for solutions and mixtures.

• Ratios: Indicates the relationship between the drug and the solvent.

Household Measurements

• Unofficial and not standardized; often leads to inaccuracies.

• Recommendation for using marked measuring tools.