KARCH PHARMACOLOGY QUESTION SET
WITH RATIONALES AND MEDICATION SAFETY
AND NURSING APPLICATION REVIEW 2026
◉ Inorganic compounds/ elements used for their therapeutic
effects.
Answer: *Aluminum* = (1)antacid to decrease gastric acidity
(2) management of hyperphosphotemia
(3) prevention of the formation of phosphate urinary stones
*Fluorine* = (1) prevention of dental cavities
(2) prevention of osteoporosis
*Gold* = treatment of rheumatoid arthritis
*Iron* = treatment of iron deficiency anemia
◉ Genetic engineering.
Answer: process of altering DNA, usually of bacteria to produce a
chemical to be used as a drug
e.g. production of human insulin by altering Escherichia coli
bacteria, making insulin a better product without some of the
impurities that come with animal products.
Thyroid drugs and growth hormone preparations are not created
synthetically
,◉ Food and Drug Administration (FDA).
Answer: federal agency responsible for the regulation and
enforcement of development and sale of drugs. FDA regulated tests
are designed to ensure the safety and reliability of any drug
approved in this country.
◉ Preclinical trials.
Answer: initial trial of a chemical thought to have therapeutic
potential; uses laboratory animals, not human subjects
PURPOSE:
- to determine whether they have the presumed effects in living
tissue
- to evaluate any adverse effects
◉ Why are some chemicals discarded at the end of preclinical trials?.
Answer: * the chemical lacks therapeutic activity when used with
living animals
* the chemical is *too toxic to living animals* to be worth the risk of
developing into a drug
* the chemical is highly teratogenic (causing adverse effects to the
fetus)
* the safety margins are so small that the chemical would not be
useful in the clinical setting
, ◉ Phase I study.
Answer: a pilot study of a potential drug done with a small number
of selected, healthy human male volunteers
- studies are more tightly controlled than preclinical trials
- performed by specially trained clinical investigators
- women are not selected , too much risk is involved in taking a drug
that might destroy or alter the ova
DRUGS DRopped at the end of Phase I due to :
1) lack therapeutic activity in humans
2) are too toxic
3) produce unacceptable side effects
◉ Phase II study.
Answer: a clinical study of a proposed drug by selected physicians
using actual patients who have the disorder the drug is designed to
treat; patients must provide informed consent
DRUGS REMOVED due to:
(1) less effective than anticipated
(2) are too toxic
(3) Produce unacceptable side effects
WITH RATIONALES AND MEDICATION SAFETY
AND NURSING APPLICATION REVIEW 2026
◉ Inorganic compounds/ elements used for their therapeutic
effects.
Answer: *Aluminum* = (1)antacid to decrease gastric acidity
(2) management of hyperphosphotemia
(3) prevention of the formation of phosphate urinary stones
*Fluorine* = (1) prevention of dental cavities
(2) prevention of osteoporosis
*Gold* = treatment of rheumatoid arthritis
*Iron* = treatment of iron deficiency anemia
◉ Genetic engineering.
Answer: process of altering DNA, usually of bacteria to produce a
chemical to be used as a drug
e.g. production of human insulin by altering Escherichia coli
bacteria, making insulin a better product without some of the
impurities that come with animal products.
Thyroid drugs and growth hormone preparations are not created
synthetically
,◉ Food and Drug Administration (FDA).
Answer: federal agency responsible for the regulation and
enforcement of development and sale of drugs. FDA regulated tests
are designed to ensure the safety and reliability of any drug
approved in this country.
◉ Preclinical trials.
Answer: initial trial of a chemical thought to have therapeutic
potential; uses laboratory animals, not human subjects
PURPOSE:
- to determine whether they have the presumed effects in living
tissue
- to evaluate any adverse effects
◉ Why are some chemicals discarded at the end of preclinical trials?.
Answer: * the chemical lacks therapeutic activity when used with
living animals
* the chemical is *too toxic to living animals* to be worth the risk of
developing into a drug
* the chemical is highly teratogenic (causing adverse effects to the
fetus)
* the safety margins are so small that the chemical would not be
useful in the clinical setting
, ◉ Phase I study.
Answer: a pilot study of a potential drug done with a small number
of selected, healthy human male volunteers
- studies are more tightly controlled than preclinical trials
- performed by specially trained clinical investigators
- women are not selected , too much risk is involved in taking a drug
that might destroy or alter the ova
DRUGS DRopped at the end of Phase I due to :
1) lack therapeutic activity in humans
2) are too toxic
3) produce unacceptable side effects
◉ Phase II study.
Answer: a clinical study of a proposed drug by selected physicians
using actual patients who have the disorder the drug is designed to
treat; patients must provide informed consent
DRUGS REMOVED due to:
(1) less effective than anticipated
(2) are too toxic
(3) Produce unacceptable side effects
