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Scientific Foundations > Lecture 65 > Flashcards

Lecture 65 Flashcards

Introduction to Pharmacology and Drug Development, Evaluation, and Control

1
Q

pharmacology

A
  • studies how xenobitics (substances foreign to the body) affect biological systems
  • these xenobiotics may include drugs (intention to treat) used for medical purposes or chemicals encountered in the environment
  • broadly divided into: medical pharmacology & toxicology, and environmental toxicology
  • toxicology = why we use the medicine to treat

pg 1658

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2
Q

medical pharmacology

A
  • examines drugs to prevent, diagnose, and treat disease or modify body processes
  • focuses on understanding drug actions, therapeutic effects, safe dosages, and side effects to optimize treatments

pg 1659

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3
Q

environmental toxicology

A
  • investigates the harmful effects of chemicals on living organisms from cells to ecosystems
  • assesses the risks and impacts of environmental exposures, aiming to prevent and reduce chemical hazards

pg 1659

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4
Q

pharmacokinetics

A
  • study of how the body processes drugs over time = effect of the body on the drug
  • focusing on absorption, distribution, metabolism, and elimination (ADME) → sometimes add T (toxicity)
  • determine the best method of administration for each patient

pg 1660

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5
Q

pharmacodynamics

A

studies biochemical, physiological, and molecular effects of drugs on the body = effect of the drug on the body

pg 1661

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6
Q

pharmacogenomics

A

relation of the individual’s genetic makeup to his/her response to specific drugs

pg 1661

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7
Q

clinical pharmacology

A
  • involves pharmacodynamic and pharmacokinetic investigations on patients to evaluate the efficacy and safety of drugs
  • pharmacodynamics: onset of action, duration of action, intensity of action
  • pharmacokinetics: absorption phase, absorption rate = elimination rate, post-absorption phase, elimination phase

pg 1662

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8
Q

principles to remember

A
  1. all substances can under certain circumstances be toxic, even water
  2. botanical chemicals (in herbs and plant extracts) are similar to those in manufactured drugs but with more impurities
  3. dietary supplements should meet the same efficacy and safety standards as drugs, verified through randomized controlled trials

pg 1663

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9
Q

nature of drugs

A
  • drugs induce changes in biological function through their chemical effects
  • drug molecules are either agonists (activators) or antagonists (inhibitors) to specific receptors
  • drugs can have therapeutic effects, side effects, or toxic effects (poisons)

pg 1664

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10
Q

therapeutic effect

A

primary intended effect of the drug (aspirin → analgesic)

pg 1664

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11
Q

side effect

A
  • secondary effect of the drug
  • unintended, usually predictable, and may be harmless or toxic

pg 1664

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12
Q

poisons

A
  • almost exclusively harmful
  • dose makes the poison → any substance can be harmful if taken in the wrong dosage

pg 1665

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13
Q

toxins

A
  • biologic poisons = plants or animals
  • inorganic poisons = lead and arsenic

pg 1665

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14
Q

immunopharmacology

A

study the effects of drugs on the immune response and production of antibodies

pg 1665

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15
Q

drug allergy

A

immunological reaction to a drug

pg 1665

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16
Q

tolerance

A

a decreasing response to repetitive drug doses

pg 1665

17
Q

drug misuse

A

improper use of common medications in a way that leads to acute and chronic toxicity

pg 1666

18
Q

drug abuse

A

inappropriate intake of drug (continually or periodically)

pg 1666

19
Q

drug dependence

A

a person’s reliance on or need to take drug or substance

pg 1666

20
Q

dose

A

quantity of the drug that achieves the therapeutic effect without causing harmful side effect

pg 1666

21
Q

therapeutic index

A

measures the danger of poisoning → the higher the index, the safer the drug is

pg 1666

22
Q

physical nature of drugs

A

the drug must have:

  1. appropriate size of the molecule
  2. electrical charges
  3. molecular shape
  4. atomic composition
  5. hydrophilicity (body is mostly water)
  6. hydrophobicity (lipophilicity) → needs to pass through lipid membranes
  • to be absorbed, distributed in the body, interact with receptors, metabolized & excreted from the body at a reasonable rate = provide actions of appropriate duration
  • these factors often determine the best route of administration

pg 1667

23
Q

drug molecular size

A
  • most drugs molecular weight between 100 to 1000 Da
  • drugs&raquo_space; 1000 Da do not diffuse readily between compartments of the body and must be administered directly into the compartment where they have their effect

pg 1668

24
Q

drug reactivity and drug-receptor bonds

A

drugs interact with receptors by chemical forces or bonds

pg 1669

25
Q

covalent bonds

A
  • very strong and irreversible under biological conditions
  • example: bond between the acetyl group of Aspirin and cyclooxygenase → blocks platelet aggregation for a long time and is reversed only by the synthesis of a new enzyme which takes several days (7-10 days for platelet turnover)

pg 1669

26
Q

electrostatic bonding, weak hydrogen bonding, Van der Waals forces, hydrophobic bonds

A
  • electrostatic bonding: strong linkages between permanently charged ionic molecules
  • weak hydrogen bonding
  • Van der Waals forces: very weak induced dipole interactions
  • hydrophobic bonds: quite weak; between lipid-soluble drugs and the lipids of cell membranes or with receptor surfaces

pg 1670

27
Q

drug shape

A
  • a drug must have a certain configuration complementary to the receptor → lock and key effect
  • active enantiomer at one receptor is NOT the active enantiomer at another receptor
  • drugs containing both chiral forms are called racemic mixtures

pg 1671-1672

28
Q

drug chirality

A
  • 50% of drugs are chiral
  • exist as enantiomeric pairs → same chemical and structural formula, but one is the mirror image of the other
  • only the one that is correctly oriented will fit into the receptor

pg 1671

29
Q

types of drug-receptor interactions

A
  • agonist: drug binds to receptor = activation = effect
  • full agonist: has high efficacy, producing a full response while occupying a relatively low proportion of receptors
  • partial agonists: produce sub-maximal activation even when occupying the total receptor population
  • competitive antagonist: binds to the same site as the agonist but does NOT activate it, thus blocking the agonist’s action

pg 1673

30
Q

allosteric inhibition

A
  • drugs binding allosterically to the same receptor as the agonist can enhance or inhibit the agonist’s action
  • allosteric inhibition is typically not overcome by increasing the agonist dose
  • allosteric activators increase the efficacy of the agonist or its binding affinity

pg 1674

31
Q

drug groups

A
  • several thousand drugs can be arranged into ~70 drugs
  • many drugs within each group are similar in pharmacodynamic and pharmacokinetic properties
  • 1 or 2 prototype drugs are the most important of the group
  • other significant drugs in the group are variations of the prototype

pg 1675

32
Q

new drug development and regulation

A
  • the process of drug discovery and development from initial identification of a molecule to preclinical testing before human trials
    1. discovery → synthesizing or extracting a new drug
    2. target interaction → study interaction with biological targets
    3. optimization → create analogs to improve
    4. in vitro/in vivo testing
    5. pharmacokinetics and safety → evaluate drug behavior and safety in animals
    6. human testing → with regulatory approval (3 clinical phases)
    7. drug approval for marketing
    8. IRB makes sure rights and welfare of participants are protected
    9. post-marketing surveillance
    10. after patent expires, any company can produce drug (abbreviated new drug application - ANDA)
    11. FDA approval to market drug as generic product

pg 1676-1678

33
Q

trademark

A

drug’s proprietary trade name and is usually registered; legally protected as long as it is used

pg 1679

34
Q

Food & Drug Administration (FDA)

A
  • administrative body that oversees the drug evaluation process in the USA and grants approval for the marketing of new drug products
  • if a drug is effective and unsafe, cannot be marketed in interstate commerce
  • complete absence of risk in FDA approved drugs is impossible
  • history of drug regulation in the USA reflects several health events that precipitated major shifts in public opinion

pg 1680

Scientific Foundations (46 decks)

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