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Questions and Answers
Which of the following is a phase in the drug approval process that involves testing on a very low dose in human subjects?
Which of the following is a phase in the drug approval process that involves testing on a very low dose in human subjects?
Traditional healers do not play a role in health practices worldwide.
Traditional healers do not play a role in health practices worldwide.
False
Name one component required on dietary supplement labels.
Name one component required on dietary supplement labels.
Name of the supplement Amount of the supplement (net quantity) Nutrition labeling Ingredient list Name and place of the manufacturer
The drug approval process includes clinical trials that assess safety and __________ in human beings.
The drug approval process includes clinical trials that assess safety and __________ in human beings.
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Match the following phases of clinical trials with their descriptions:
Match the following phases of clinical trials with their descriptions:
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Which act defined dietary supplements and their intended use?
Which act defined dietary supplements and their intended use?
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Drugs can only be tested on patients with the targeted disease after they have successfully gone through Phase I trials.
Drugs can only be tested on patients with the targeted disease after they have successfully gone through Phase I trials.
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What is the purpose of an IND application in the drug approval process?
What is the purpose of an IND application in the drug approval process?
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At what age does the Glomerular Filtration Rate (GFR) reach adult levels?
At what age does the Glomerular Filtration Rate (GFR) reach adult levels?
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As people age, total body water and lean body mass increase, leading to decreased body fat.
As people age, total body water and lean body mass increase, leading to decreased body fat.
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Name two drug classes that require dosage adjustment in chronic kidney disease.
Name two drug classes that require dosage adjustment in chronic kidney disease.
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The process of using professional translators when patients and healthcare providers speak different __________ is important for safeguarding confidentiality.
The process of using professional translators when patients and healthcare providers speak different __________ is important for safeguarding confidentiality.
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Match the following physiological changes in older adults with their effects on drug therapy:
Match the following physiological changes in older adults with their effects on drug therapy:
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Which of the following cultural phenomena focuses on how people organize themselves socially?
Which of the following cultural phenomena focuses on how people organize themselves socially?
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Culturally competent care only pertains to verbal communication between healthcare providers and patients.
Culturally competent care only pertains to verbal communication between healthcare providers and patients.
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What happens to the hepatic clearance of drugs as liver size and blood flow decrease in older adults?
What happens to the hepatic clearance of drugs as liver size and blood flow decrease in older adults?
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What aspect of pharmacokinetics is particularly complicated in children?
What aspect of pharmacokinetics is particularly complicated in children?
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Cultural beliefs influence decisions on dietary practices and consuming herbal remedies.
Cultural beliefs influence decisions on dietary practices and consuming herbal remedies.
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What is ethnopharmacology?
What is ethnopharmacology?
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In neonates, the body is composed of approximately _____% water.
In neonates, the body is composed of approximately _____% water.
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Which of these factors can affect drug absorption in children?
Which of these factors can affect drug absorption in children?
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Match the following drug therapies or considerations to their correct descriptions:
Match the following drug therapies or considerations to their correct descriptions:
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The distribution of drugs in the body is solely determined by age.
The distribution of drugs in the body is solely determined by age.
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What are some effects that traditional health practices can have on a patient's health?
What are some effects that traditional health practices can have on a patient's health?
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Study Notes
Drug Approval Process
- A promising drug candidate undergoes preclinical studies (in vitro and in vivo) before entering human clinical trials.
- Investigational New Drug (IND) application is filed with the FDA (Food and Drug Administration) for clinical trials.
- Phase 0 trials use a very low dose of the drug on a small number of human subjects (10-15) to assess its pharmacokinetic and pharmacodynamic properties.
- Phases I-III assess safety and efficacy in humans, with increasing patient populations and study durations.
- Drug manufacturers file a New Drug Application (NDA) to obtain FDA approval to market the drug after successful completion of all three clinical trial phases.
Dietary Supplements
- The Dietary Supplement Health and Education Act of 1984 defines dietary supplements as products intended to supplement the diet.
- Dietary supplements contain one or more dietary ingredients, including vitamins, minerals, and herbs.
- Dietary supplements are typically intended for oral consumption in various forms, such as tablets, capsules, powders, soft gels, gelcaps, and liquids.
- Labels for dietary supplements must include the product's name, net quantity, nutritional information, ingredients, and the manufacturer's name and location.
Drug Therapy in Older Adults
- Elderly patients experience physiologic changes that affect drug pharmacokinetics.
- Reduction in total body water and lean body mass leads to increased body fat, impacting drug distribution.
- Decreased kidney mass and blood flow result in lower glomerular filtration rate (GFR) and reduced clearance of drugs excreted by the kidneys.
- Reduced liver size and blood flow cause decreased hepatic clearance of drugs.
Cultural Considerations
- Giger and Davidhizar's cultural phenomena framework includes six key aspects: communication, space, social organization, time, environmental control, and biologic variation.
- Communication occurs verbally and nonverbally, requiring nurses to be aware of diverse communication styles to provide culturally competent care.
- Professional translators should be used whenever possible to ensure patient confidentiality when language barriers exist.
- Ethnopharmacology explores the use of herbal remedies, powders, teas, and animal products within different cultures.
Drug Therapy in Children
- Pharmacokinetic studies in children are challenging due to limited blood sample volumes and the potential for pain perception.
- Drug absorption can differ in children as gut transit time and intestinal fluid composition influence drug dissolution.
- Intestinal transit time tends to be shorter in young children, potentially reducing drug absorption, particularly for poorly soluble drugs or sustained-release products.
- Drug distribution in children is affected by factors like body fluid composition, tissue composition, protein binding, and barrier effectiveness.
Cultural Considerations
- Ethnopharmacology focuses on the use of herbs, powders, teas, and animal products as traditional healing remedies.
- These traditional practices can have neutral, beneficial, or harmful effects on a patient's health.
- Nurses must utilize research from social sciences, alongside biological and physical sciences, to provide holistic culturally competent care.
- Culture is learned and shared by a group of people, encompassing beliefs, behaviors, symbols, artifacts, institutions, values, morals, and rules.
- Universals like the need for food are biologically driven, while cultural influences dictate what and how food is consumed.
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Description
This quiz covers the essential steps in the drug approval process, including preclinical studies, IND applications, and clinical trial phases. It also highlights the regulatory context of dietary supplements as defined by the Dietary Supplement Health and Education Act of 1984. Test your knowledge on these crucial topics in pharmaceutical and dietary regulations.
