Analytical and Active Markers
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Questions and Answers

Pharmacognosy is defined as the science of

  • synthetic pharmaceuticals
  • biogenic or nature-derived pharmaceuticals and poisons (correct)
  • herbal medicine
  • pharmaceutical drug delivery systems

    • Which research area of Pharmacognosy studies the relationship between humans and plants?

  • Ethnopharmacy
  • Toxicology
  • Pharmacology
  • Ethnobotany (correct)

    • What does bioavailability measure?

  • The cultural practices associated with the use of plants
  • The rate and extent to which a drug reaches the site of action (correct)
  • The effect of a drug on the body
  • The toxicity of a drug

    • Which documents form the basis for the required individual medicinal product information?

    <p>Monographs</p> Signup and view all the answers

    What has the World Health Organization defined as pharmacovigilance?

    <p>The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem</p> Signup and view all the answers

    What are some methods used in pharmacovigilance?

    <p>Spontaneous reporting, Single case report, Case series, Cohort studies, Case control studies, Randomized clinical trial</p> Signup and view all the answers

    Which of the following is the definition of 'novel food' according to the text?

    <p>All of the above</p> Signup and view all the answers

    What are cosmeceuticals?

    <p>Cosmetic products with medical benefits</p> Signup and view all the answers

    What is the purpose of standardized extracts?

    <p>To adjust the content of constituents with known therapeutic activity</p> Signup and view all the answers

    What are markers in the context of herbal substances?

    <p>Chemically defined constituents used for control purposes</p> Signup and view all the answers

    Which type of registration requires no clinical tests and trials on safety and efficacy?

    <p>Traditional use</p> Signup and view all the answers

    What does a European Union (EU) herbal monograph contain?

    <p>Safety and efficacy data about a herbal substance and its preparations</p> Signup and view all the answers

    What is the principal intended action of a medical device?

    <p>Investigation, replacement or modification of the anatomy or physiological process</p> Signup and view all the answers

    What are substance-based medical devices?

    <p>Devices made of multiple substances with non-pharmacological mechanisms</p> Signup and view all the answers

    Which one of the following is true about herbal medicines products (Phytomedicines)?

    <p>They can only be sold in pharmacies and are approved by AIFA in Italy</p> Signup and view all the answers

    Which one of the following is true about Galenic formulation?

    <p>It is a process that turns an active ingredient into a ready-to-use medicine</p> Signup and view all the answers

    Which one of the following is true about Officinal medical preparations or Magistral preparation?

    <p>They are only prepared for individual patients with a medical prescription</p> Signup and view all the answers

    Which one of the following is true about Nutraceutical products?

    <p>They provide extra health benefits but cannot claim therapeutic effect</p> Signup and view all the answers

    Which type of markers are constituents or group of constituents that serve solely for analytical purpose?

    <p>Analytical markers</p> Signup and view all the answers

    What is the purpose of the European Directive On Traditional Herbal Medicinal Products (THMPD)?

    <p>To provide a simplified regulatory approval process for traditional herbal medicines in the EU</p> Signup and view all the answers

    Which criteria must a herbal medicine meet to qualify under the THMPD legislation?

    <p>Administrated orally, externally or by inhalation</p> Signup and view all the answers

    What is the difference between traditional use and well-established use of a medicinal plant?

    <p>Traditional use requires medical use for at least 30 years, while well-established use requires medical use for at least 10 years</p> Signup and view all the answers

    Which healthcare professional represents the only study pharmacognosy?

    <p>Pharmacist</p> Signup and view all the answers

    What does ethnobotany study in relation to plants?

    <p>The relationship between humans and plants</p> Signup and view all the answers

    Which research area of Pharmacognosy studies the effect of herbal drugs?

    <p>Pharmacology</p> Signup and view all the answers

    Which organization has defined pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem?

    <p>World Health Organization (WHO)</p> Signup and view all the answers

    Which of the following methods is NOT used in pharmacovigilance?

    <p>Randomized clinical trial</p> Signup and view all the answers

    Who has a role in reporting suspected adverse reactions to herbal medicines in pharmacovigilance?

    <p>Health professionals including pharmacists</p> Signup and view all the answers

    Which of the following is true about phytotherapy?

    <p>It includes aliments, nutraceuticals, and supplements</p> Signup and view all the answers

    What is the definition of officinal medical preparations or magistral preparation?

    <p>Medicinal products prepared in a pharmacy for an individual patient</p> Signup and view all the answers

    What are homeopathic medicinal products?

    <p>Medicinal products prepared from homeopathic stocks</p> Signup and view all the answers

    What are nutraceutical products?

    <p>Products derived from food sources that provide extra health benefits</p> Signup and view all the answers

    Which of the following is NOT considered a novel food according to the text?

    <p>Food consumed by humans in the EU before 15 May 1997</p> Signup and view all the answers

    What are cosmeceuticals?

    <p>Cosmetic products with bioactive ingredients</p> Signup and view all the answers

    What is the purpose of standardized extracts?

    <p>To contain a consistent level of major active constituent or marker compound</p> Signup and view all the answers

    What is the difference between standardized extracts and quantified extracts?

    <p>Standardized extracts are adjusted to one or more active markers, while quantified extracts are adjusted to defined content of one or more constituents</p> Signup and view all the answers

    Which committee is responsible for preparing herbal monographs and a list of herbal substances, preparations, and combinations?

    <p>Herbal Medicinal Products Committee (HMPC)</p> Signup and view all the answers

    What is the minimum number of years of medical use required for a medicinal plant to be considered as having traditional use?

    <p>30 years</p> Signup and view all the answers

    Which types of herbal medicines will not be regarded as herbal medicines and will not receive authorization under the THMPD legislation?

    <p>Herbal medicines with isolated active ingredients from plants</p> Signup and view all the answers

    What is the purpose of the European Directive On Traditional Herbal Medicinal Products (THMPD)?

    <p>To provide a simplified regulatory approval process for traditional herbal medicines in the EU</p> Signup and view all the answers

    Which one of the following is true about the registration process for traditional use medicinal products?

    <p>Bibliographic safety and efficacy data are assessed.</p> Signup and view all the answers

    What is the purpose of a European Union (EU) herbal monograph?

    <p>To define the regulations for the marketing of herbal products.</p> Signup and view all the answers

    Which one of the following is true about substance-based medical devices?

    <p>They are composed of a high number of molecules.</p> Signup and view all the answers

    What is the principal intended action of a medical device?

    <p>Non-pharmacological action.</p> Signup and view all the answers

    Which of the following is NOT a method used in pharmacovigilance?

    <p>Clinical trial</p> Signup and view all the answers

    What is the role of health professionals in pharmacovigilance?

    <p>To report adverse reactions to herbal medicines</p> Signup and view all the answers

    What is the general concept often held in the market and by the media about natural products?

    <p>They are always safe</p> Signup and view all the answers

    Which of the following is NOT considered a novel food according to the text?

    <p>Milk</p> Signup and view all the answers

    What are cosmeceuticals?

    <p>Cosmetic products with medical benefits</p> Signup and view all the answers

    What is the purpose of standardized herbal products?

    <p>To contain a consistent level of major active constituent or marker compound</p> Signup and view all the answers

    What are markers in the context of herbal substances?

    <p>Chemically defined constituents of interest for control purpose</p> Signup and view all the answers

    Which of the following is true about traditional use of herbal medicines?

    <p>Marketing authorization is not required</p> Signup and view all the answers

    What is the purpose of a European Union (EU) herbal monograph?

    <p>To provide information on the use of herbal products</p> Signup and view all the answers

    What is the definition of a medical device?

    <p>An instrument used for diagnosis and treatment without pharmacological action</p> Signup and view all the answers

    What are substance-based medical devices?

    <p>Health products with multiple non-pharmacological mechanisms of action</p> Signup and view all the answers

    Which of the following is true about herbal medicines products (Phytomedicines)?

    <p>They can only be sold in pharmacies in Italy.</p> Signup and view all the answers

    What is the difference between Galenic formulation and Officinal medical preparations or Magistral preparation?

    <p>Galenic formulation is a process that turns an active ingredient into a ready-to-use medicine, while Officinal medical preparations or Magistral preparation are specific medicinal products prepared for individual patients.</p> Signup and view all the answers

    Which of the following is true about Homeopathic medicinal products?

    <p>They involve the use of minute amounts of substances that are more diluted.</p> Signup and view all the answers

    What is the purpose of Nutraceutical products?

    <p>To provide extra health benefits in addition to basic nutritional value.</p> Signup and view all the answers

    Which of the following is a requirement for a herbal medicine to qualify for simplified registration under the European Directive On Traditional Herbal Medicinal Products (THMPD)?

    <p>The herbal medicine must have a traditional history or recognised pharmacological properties</p> Signup and view all the answers

    What is the purpose of the Herbal Medicinal Products Committee (HMPC) mentioned in the text?

    <p>To prepare herbal monographs for the authorization of herbal medicinal products</p> Signup and view all the answers

    What is the difference between traditional use and well-established use of a medicinal plant?

    <p>Traditional use refers to medical use for at least 30 years, while well-established use refers to medical use for at least 10 years</p> Signup and view all the answers

    What does the European Directive On Traditional Herbal Medicinal Products (THMPD) aim to provide?

    <p>Simplified regulatory approval process for traditional herbal medicines in the EU</p> Signup and view all the answers

    Which research area of Pharmacognosy focuses on the interdisciplinary scientific exploration of biologically active agents traditionally employed or observed by humans?

    <p>Ethnopharmacology</p> Signup and view all the answers

    What is the term used to describe the measurement of the rate and extent to which a drug reaches the site of action?

    <p>Bioavailability</p> Signup and view all the answers

    Which healthcare professional plays a key role in advising consumers on the safe and appropriate use of all medicines, including herbal medicine?

    <p>Pharmacist</p> Signup and view all the answers

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