66 Questions
Pharmacognosy is defined as the science of
biogenic or nature-derived pharmaceuticals and poisons
Which research area of Pharmacognosy studies the relationship between humans and plants?
Ethnobotany
What does bioavailability measure?
The rate and extent to which a drug reaches the site of action
Which documents form the basis for the required individual medicinal product information?
Monographs
What has the World Health Organization defined as pharmacovigilance?
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem
What are some methods used in pharmacovigilance?
Spontaneous reporting, Single case report, Case series, Cohort studies, Case control studies, Randomized clinical trial
Which of the following is the definition of 'novel food' according to the text?
All of the above
What are cosmeceuticals?
Cosmetic products with medical benefits
What is the purpose of standardized extracts?
To adjust the content of constituents with known therapeutic activity
What are markers in the context of herbal substances?
Chemically defined constituents used for control purposes
Which type of registration requires no clinical tests and trials on safety and efficacy?
Traditional use
What does a European Union (EU) herbal monograph contain?
Safety and efficacy data about a herbal substance and its preparations
What is the principal intended action of a medical device?
Investigation, replacement or modification of the anatomy or physiological process
What are substance-based medical devices?
Devices made of multiple substances with non-pharmacological mechanisms
Which one of the following is true about herbal medicines products (Phytomedicines)?
They can only be sold in pharmacies and are approved by AIFA in Italy
Which one of the following is true about Galenic formulation?
It is a process that turns an active ingredient into a ready-to-use medicine
Which one of the following is true about Officinal medical preparations or Magistral preparation?
They are only prepared for individual patients with a medical prescription
Which one of the following is true about Nutraceutical products?
They provide extra health benefits but cannot claim therapeutic effect
Which type of markers are constituents or group of constituents that serve solely for analytical purpose?
Analytical markers
What is the purpose of the European Directive On Traditional Herbal Medicinal Products (THMPD)?
To provide a simplified regulatory approval process for traditional herbal medicines in the EU
Which criteria must a herbal medicine meet to qualify under the THMPD legislation?
Administrated orally, externally or by inhalation
What is the difference between traditional use and well-established use of a medicinal plant?
Traditional use requires medical use for at least 30 years, while well-established use requires medical use for at least 10 years
Which healthcare professional represents the only study pharmacognosy?
Pharmacist
What does ethnobotany study in relation to plants?
The relationship between humans and plants
Which research area of Pharmacognosy studies the effect of herbal drugs?
Pharmacology
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?
World Health Organization (WHO)
Which of the following methods is NOT used in pharmacovigilance?
Randomized clinical trial
Who has a role in reporting suspected adverse reactions to herbal medicines in pharmacovigilance?
Health professionals including pharmacists
Which of the following is true about phytotherapy?
It includes aliments, nutraceuticals, and supplements
What is the definition of officinal medical preparations or magistral preparation?
Medicinal products prepared in a pharmacy for an individual patient
What are homeopathic medicinal products?
Medicinal products prepared from homeopathic stocks
What are nutraceutical products?
Products derived from food sources that provide extra health benefits
Which of the following is NOT considered a novel food according to the text?
Food consumed by humans in the EU before 15 May 1997
What are cosmeceuticals?
Cosmetic products with bioactive ingredients
What is the purpose of standardized extracts?
To contain a consistent level of major active constituent or marker compound
What is the difference between standardized extracts and quantified extracts?
Standardized extracts are adjusted to one or more active markers, while quantified extracts are adjusted to defined content of one or more constituents
Which committee is responsible for preparing herbal monographs and a list of herbal substances, preparations, and combinations?
Herbal Medicinal Products Committee (HMPC)
What is the minimum number of years of medical use required for a medicinal plant to be considered as having traditional use?
30 years
Which types of herbal medicines will not be regarded as herbal medicines and will not receive authorization under the THMPD legislation?
Herbal medicines with isolated active ingredients from plants
What is the purpose of the European Directive On Traditional Herbal Medicinal Products (THMPD)?
To provide a simplified regulatory approval process for traditional herbal medicines in the EU
Which one of the following is true about the registration process for traditional use medicinal products?
Bibliographic safety and efficacy data are assessed.
What is the purpose of a European Union (EU) herbal monograph?
To define the regulations for the marketing of herbal products.
Which one of the following is true about substance-based medical devices?
They are composed of a high number of molecules.
What is the principal intended action of a medical device?
Non-pharmacological action.
Which of the following is NOT a method used in pharmacovigilance?
Clinical trial
What is the role of health professionals in pharmacovigilance?
To report adverse reactions to herbal medicines
What is the general concept often held in the market and by the media about natural products?
They are always safe
Which of the following is NOT considered a novel food according to the text?
Milk
What are cosmeceuticals?
Cosmetic products with medical benefits
What is the purpose of standardized herbal products?
To contain a consistent level of major active constituent or marker compound
What are markers in the context of herbal substances?
Chemically defined constituents of interest for control purpose
Which of the following is true about traditional use of herbal medicines?
Marketing authorization is not required
What is the purpose of a European Union (EU) herbal monograph?
To provide information on the use of herbal products
What is the definition of a medical device?
An instrument used for diagnosis and treatment without pharmacological action
What are substance-based medical devices?
Health products with multiple non-pharmacological mechanisms of action
Which of the following is true about herbal medicines products (Phytomedicines)?
They can only be sold in pharmacies in Italy.
What is the difference between Galenic formulation and Officinal medical preparations or Magistral preparation?
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.
Which of the following is true about Homeopathic medicinal products?
They involve the use of minute amounts of substances that are more diluted.
What is the purpose of Nutraceutical products?
To provide extra health benefits in addition to basic nutritional value.
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)?
The herbal medicine must have a traditional history or recognised pharmacological properties
What is the purpose of the Herbal Medicinal Products Committee (HMPC) mentioned in the text?
To prepare herbal monographs for the authorization of herbal medicinal products
What is the difference between traditional use and well-established use of a medicinal plant?
Traditional use refers to medical use for at least 30 years, while well-established use refers to medical use for at least 10 years
What does the European Directive On Traditional Herbal Medicinal Products (THMPD) aim to provide?
Simplified regulatory approval process for traditional herbal medicines in the EU
Which research area of Pharmacognosy focuses on the interdisciplinary scientific exploration of biologically active agents traditionally employed or observed by humans?
Ethnopharmacology
What is the term used to describe the measurement of the rate and extent to which a drug reaches the site of action?
Bioavailability
Which healthcare professional plays a key role in advising consumers on the safe and appropriate use of all medicines, including herbal medicine?
Pharmacist
Test your knowledge on analytical markers and active markers in the context of the European Directive on pharmaceuticals. Learn about the role of these constituents and how they contribute to therapeutic activity.
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