Week 1+2-Introduction to Pharmaceutical Sciences and Drugs Exam 1 Review

What are the pharmaceutical sciences?

A group of interdisciplinary areas of study involved with the design, action, delivery, disposition, and use of drugs

What are the 4 most important words in pharmaceutical science?

safety, efficacy, quality, and patient compliance

What is pharmacology?

Study of biomedical and physiological effects of drugs on organisms

What is the purpose of pharmacodynamics?

What the drug does to the body

What is the purpose of pharmacokinetics?

What the body does to the drug. Studies absorption, distribution, metabolism, and excretion

What does ADME stand for in pharmacokinetics?

absorption, distribution, metabolism, excretion

Where within pharmacology would mechanism of drug action fall?

pharmacodynamics

What is pharmacogenomics?

the study of how genes affect a person's response to drugs

What area of pharmacology deals with genes and how they affect a person's response to drugs

pharmacogenomics

What is pharmaceutical/ medicinal chemistry?

Study of drug design to synthesize new drug molecules

What is QSAR?

Quantitative Structure-Activity Relationship

What is pharmaceutics?

study of formulating a drug into a dosage form for optimal delivery, stability, pharmacology, and patient compliance

What area of pharmacology deals with the formulation of drugs into a dosage for optimal pharmacology?

Pharmaceutics

What is pharmacognosy?

the area of pharmacology that deals with natural origin of drugs and search for new drugs from natural origins

What makes an ideal drug?

-Desirable pharmacological action

-Specific and selective

-few side effects

-bioavailability

-excretion

What is bioavailability?

amount of drug that actually reaches the target

What is USAN?

United States Adopted Names

What are two ways that drugs work?

Directly and Indirectly

How do most drugs work?

Indirectly

What are the five principles of drug action?

1.Stimulation

2.Depression

3.Irritation

4.Replacement

5.Cytotoxic Action

What type of source of drug is recombinant DNA technolgy?

Biosynthetic Source

Why is the physical state of a drug important?

state effects how a drug can be formulated and delivered

What type of solid is one that is a disordered arrangement of molecules that does not have a crystal lattice?

Amorphous

What type of solid is one that is highly ordered and held together by non covalent interactions with a distinguished crystal lattice

Crystalline

What are the three main routes of administration for drugs?

Enteral, Parenteral, Topical

What type of administration is via oral tablets, capsules, or liquids?

Enteral

What type of administration is via an injection or an infusion?

Parenteral

What type of administration is via inhalations, eye drops, intranasal, or epicutaneously?

Topical

How are vasodilator drugs administered?

Intra-arterial

How are many vaccines and antibiotics administered?

Intramuscular

How is a drug like adrenalin administered?

Intra-cardiac

How is insulin administered?

subcutaneously

How is allergy testing done?

Intradermal

How is peritoneal dialysis performed?

intra-paritoneal

How are opioid patches administered?

Transdermal

What are the different topical administration methods?

Inhalation, Epicutaneous, Intranasal, Eye Drops

What type of injection is a high velocity jet produced through a micro fine orifice?

Jet Injection

What is a use of mild current to penetrate drugs?

lontophoresis

What does it mean if a drug acts directly?

Drug acts directly instead of targeting a biomolecule.

Is an amorphous solid more stable or less stable than a crystalline solid?

Less

Are amorphous solids more or less soluble that crystalline solids?

more soluble

What is the rate and extent of water vapor uptake by a solid at a certain humidity values and temperature?

Hygroscopicity

Is hygroscopicity a favorable quality in drugs?

No

What are 4 factors that contribute to degradation?

heat, water, light, oxygen

What are liquid drugs?

Pure chemicals that exist as liquids

If a drug is impure will the melting point go up or down?

Decrease

As molecular weight increases what happens to the melting point?

Melting Point increases

What happens to boiling point as molecular size increases?

goes up

What is the amount of a solute that can be dissolved in a solvent under given conditions?

Solubility

What is the dissolved substance?

solute

What is the dissolving medium>

Solvent

What is the process of dissolving?

solvation

What is the process of dissolving in water?

hydration

What is the common use for the partition coefficient?

lipophilicty

What happens to an electrolyte when dissolved in water?

complete ionization

What happens when a weak electrolyte is dissolved in water?

partial dissocation

Do ionized or unionized have higher aqueous solubility?

ionized

Do ionized or unionized have a higher lipid solubility?

unionized

How many years does the drug development process typically take?

12 to 15 years

What is risky about the drug development process?

Developers do not know if they actually will end up with a drug at the end of the process

What is the cost associated with new drug development?

Over a billion dollars

What are preclinical trials?

Testing that occurs before human trials. Happens on animals and lab testing occurs

What is a clinical trial?

When a new drug is tested on human subjects

What is phase one of the clinical trial?

Testing in healthy subjects

What is phase two of clinical trials?

Testing in individuals with the disease

What is phase three of clinical trials?

Larger scale testing of patients with the disease

What occurs after the clinical trials for a new drug?

FDA reviews the NDA

What occurs after FDA approval?

manufacturing of the drug begins for public use

What act prohibits the interstate commerce of misbranded and adulterated foods and drug?

Pure Food and Drugs Act

What act required the demonstration of safety for new drugs by providing safety standards?

Federal Food, Drug and Cosmetic Act

What happened as a result of the sulphanilamide disaster?

Many children died as a result of diethylene glycol poisoning

What act relates to the licensing and marketing of biological drug products?

Public Health Service Act

What act separated prescription and non prescription drugs and required that some drugs be labeled for sale by prescription only?

Durham-Humphrey Amendment

What amendments were responsible for making manufactures have to prove drug effectiveness and safety and adverse effects to the FDA?

Kefauver-Harris Drug amendment

What act forced the pharmaceutic industry to maintain physical security and very strict record keeping?

Comprehensive Drug abuse prevention and control act

What act requires drug companies to provide the fda with a current list of all the drugs they manufacture so the drugs can be identified using NDC numbering system?

Drug Listing Act

What act was created to encourage the development of drugs that treat rare diseases?

Orphan Drug Act

What act allows drug manufacturers a simple process to file a ANDA to market a generic drug?

Hatch-Waxman Act

What act was intended to reduce the risk of adultered, misbranded, repackaged, or mislabeled drugs entering the USA through secondary sources and prohibit the selling of samples?

Prescription Drug Marketing Act

What act allowed the FDA to collect fees from drug manufacturers to fund new drug approval processes?

Prescription Drug User Fee Act

What act addressed the need to regulate the labeling claims of various supplements and drugs?

Dietary Supplement Health and Education Act

What are the FDA's strongest labeling requirements for high risk medications?

black box warning

What type of recall is associated with serious adverse health consequences or death?

Class I

What type of recall is associated with temporary or reversible adverse effects?

Class II

What type of recall is associated with exposure is not likely to cause adverse effects?

Class III

What is an IND for?

It is when a company asks for permission to conduct clinical trials

What is an NDA for?

When a company asks for permission to market a drug

What does an ANDA do?

It allows a manufacturer to sell a drug under a generic version

What act occurred as a result of the thalidomide disaster?

Kefauver-Harris Drug Amendment

What act occurred as a result of the Sulphanilamide disaster?

Federal, Food, Drug, and Cosmetic Act

What area of pharmaceutical sciences would deal with the relationship between dose and effects?

Pharmacodynamics

What area of pharmacy study includes QSAR

Medicinal Chemistry

What type of drugs are administered trans mucosal

sublingual

What is it called when drug is put into the epidural space?

Epidural

What is it called when drug is administered into the cerebrospinal fluid?

Intrathecal

What does it mean if the partition coefficient is very high?

too lipophilic

What does it mean if drug is administered to the bone marrow?

intra-osseous infusion

What does it mean if the partition coefficient is very low?

very polar

What are examples of drugs in the gas form?

nitrous oxide, cyclopropane, xenon

What are some cons of enteral methods of drug administration?

slow action, absorption unpredictable, first pass metabolism