Drug Development Process Flashcards

1
Q

Define Aetiology

A

The cause, set of causes or the manner of causation of a disease or condition

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2
Q

What are the two factors to consider for aetiology? What do these two causes lead to?

A
  1. Genetic Factors
  2. Environmental Factors

Both these factors lead to dysfunction.

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3
Q

Dysfunction can be defined/analyzed/connected to 3 spectrum’s. What are they?

Of the three spectrum, which utilize drugs? Provide an example of a drug for the spectrum(s).

A
  1. Diagnostic Signs
    -> Diagnostic tests used to help diagnose a medical condition
    -> e.g. Radioactive tracers for cancer diagnosis
  2. Symptoms and Disabilities
    -> A mental or physical feature t6hat presents itself with a medical condition
    -> e.g. cough syrup to help treat a cough
  3. Prognosis
    -> The likely course of a medical condition
    -> e.g. Inhaler for asthma and/or COPD -> prevents the disease that a person lives with from getting worse

DRUGS ARE USED IN ALL 3 SPECTRUM

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4
Q

Define “Drug”

What is the Greek root word of drug?

A

An agent intended for use in diagnosis, treatment, cure or prevention of disease in humans or animals

Pharmacon

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5
Q

True/False - A drug is a poison and alters/changes the biology of a person

A

True

Drugs are considered poison even if they provide therapeutic effects. Every drug has the ability to alter biology and the potential to have adverse effects. If a drug is given to a healthy individual, one is poisoning that individual.

Examples:

  • Anti Cancer Drugs –> Specific mechanism of action. Acts as a poison to help kill fast multiplying cells.
  • Nutraceuticals –> Supplements. Less of a worry as water soluble vit. simply excreted; however, if some in high doses can be toxic.
  • Contraceptives –> Still considered a poison; however, has a specific purpose for use.
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6
Q

What is a lead compound? What makes a lead compound different than a drug?

A

A prototype chemical compound which has a fundamental desired biological or pharmacological activity.

A lead compound is not considered a drug as it may not posses all desired features of a drug (potency, absorbability, solubility, toxicity)

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7
Q

What is a pro-drug? Why are pro-drugs used? (Hint: 6 Reasons)

A

A pro drug is a compound that requires metabolic biotransformation after administration to be active

  1. Drug Solubility (want optimal solubility)
  2. Site Specificity (targeting) -> target specific area, cells, enzymes, etc.
  3. Permeability –> E.g. Gut absorption and Blood Brain Barrier –> Need certain drugs to be permeable to specific membranes/barriers
  4. Extended Effects (allows the least amount of a drug to be used (less lost to metabolism) while increasing medication effectiveness
  5. Reduce Toxicity
  6. Stability on the shelf

Tony Saw PETS

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8
Q

Define Dosage Form. Provide an example.

A

Dosage Form -> the FORMULATION (form) of a drug product

The dosage form is the type of preparations in which the drug is presented to the patient. (a specific formula)

Drug delivery systems (synonymous with dosage form) is a more sophisticated preparation.

E.g. Oral Tablet vs.. Inhaler

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9
Q

What is the rationale behind dosage forms/formulation? (Why do dosage forms exist?)

A
  1. To provide a safe (not toxic) and convenient mean of administering an accurate dose of a drug (especially important for potent drugs requiring very low doses)
  2. To protect the drug against chemical decomposition from both external (atmospheric oxygen and humidity) and internal (gastric acid) environments
  3. To conceal unpleasant odour or taste
  4. To ensure or control the release of drug into the body
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10
Q

Define Drug Product. What are the 4 characteristics of a drug product?

A

A drug product is a specific preparation or formulation of a drug. (essentially the finished product - what a patient buys from the pharmacy)

It includes:

  1. Active Ingredient - The Drug
  2. Non-medicinal additives/excipients (inactive ingredients)
  3. A Finished Dosage Form
  4. Method of preparation
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11
Q

Describe the process of drug naming.

A
  1. Drugs, when first discovered, are initially represented by the EMPIRICAL FORMULA (e.g. C16H19N3O5S * 3H20 for Amoxicillin)
  2. The “new” compound will then have a chemical name
  3. When the new chemical entity shows sufficient promise as a drug, the non-propriety name is proposed (e.g. Ibuprofen, acetaminophen) (common name)
  4. When a drug product is developed and marketed, a propriety name is given (trademark) (Brand name) (e.g. Advil, Tylenol)
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12
Q

Define Propriety (brand) name. What is the benefit of using a propriety name?

A

A propriety (brand) name is a trademark officially registered by a company.

The benefit is that the company is able to make a lot of money by profiting off the popularity of the name (make a memory in the mind of consumers)

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13
Q

Define non-propriety (generic name)

A

The non-propriety name (generic name) is the generally recognized or “common” name for a drug.

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14
Q

Match the appropriate letter with the term:

a) Drug
b) Dosage Form
c) Drug Product

  1. Tablet
  2. Tylenol tablet (brand name)
  3. Acetaminophen (generic name)
A

Drug: Acetaminophen (generic name)
Dosage Form: Tablet
Drug Product: Tylenol tablet (brand name)

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15
Q

Define Pharmaceutics. What 4 characteristics is pharmaceutics concerned with?

A
  • THE SCIENCE OF DRUG FORMATION AND MANUFACTURING
  • the study of the physical, chemical and biological factors which influence the stability and effectiveness of pharmaceutical products and which should be considered in their formulation and manufacture

Pharmaceutics is concerned with:

  1. Formulation
  2. Manufacture
  3. Stability
  4. Effectiveness
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16
Q

Define Biopharmaceutics.

A

Biopharmaceutics is the study of the properties of the drug and dosage form after administration into the body

17
Q

True/False: Pharmacokinetics is a branch of biopharmaceutics.

A

True

18
Q

What are the four processes associated with pharmacokinetics?

A
  1. Absorption
  2. Distribution
  3. Metabolism
  4. Excretion
19
Q

What is the main idea of pharmacokinetics?

A

The main idea is what the body does do to the drug.

20
Q

What is the main idea of pharmacodynamics?

A

The main idea is what does the drug do to the body.

21
Q

Define new drug.

A

Any drug that has not been generally recognized as safe and effective yet.

22
Q

True/False: A drug needs to be a new chemical entity.

A

True

23
Q

What constitutes “newness” of a drug under the law?

A

A change in previously approved drug product’s formulation or manufacture constitutes newness under the law. Any changes that result in changing safety and efficacy

24
Q

How long is the drug discovery process?

A

10-12 years

25
Q

Out of 10,000 compounds in pre-clinical testing, how many enter human testing?

A

5