Introduction to Pharmaceutical Analysis
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Questions and Answers

How long does it generally take to develop a new medicine?

  • 12 years (correct)
  • 5 years
  • 8 years
  • 15 years

    • What is the average cost of developing a new medicine?

  • £250 million
  • £1 billion
  • £750 million
  • £500 million (correct)

    • At which stage of drug development is the selection of 'hits' crucial?

  • Candidate selection
  • Hit to lead (correct)
  • Screen compound library
  • Clinical phases

    • What is one of the main components in the process of developing pharmaceuticals?

    <p>Laboratory testing</p> Signup and view all the answers

    What is the average daily cost incurred during the development of a new medicine?

    <p>£114,000</p> Signup and view all the answers

    What phase follows 'Lead to Candidate' in the drug development process?

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

    Which type of scientists are involved in the new medicine development process?

    <p>Various types of scientists</p> Signup and view all the answers

    In the pharmaceutical development process, what is primarily needed during analysis?

    <p>Chemical structure verification</p> Signup and view all the answers

    What do pharmacopoeias primarily provide guidelines for?

    <p>Purity requirements for raw materials</p> Signup and view all the answers

    Which of the following is NOT a focus area when assessing a marketed pharmaceutical product?

    <p>Environmental impact of production</p> Signup and view all the answers

    What are SFFC medicines commonly associated with?

    <p>They are intentionally mislabeled regarding identity or source</p> Signup and view all the answers

    Which of the following product attributes is monitored for finished pharmaceutical preparations?

    <p>Adherence to purity standards</p> Signup and view all the answers

    What is a potential consequence of using counterfeit medicines?

    <p>Treatment failure or even death</p> Signup and view all the answers

    In terms of raw materials, what aspect do pharmacopoeias address?

    <p>Quality control methods</p> Signup and view all the answers

    What is a major concern related to counterfeiting in pharmaceuticals?

    <p>Erosion of public confidence in health systems</p> Signup and view all the answers

    Which of the following describes a critical requirement for pharmaceutical formulations?

    <p>Must adhere to defined dosages and release specifications</p> Signup and view all the answers

    What is included in the marketing authorisation document for a drug?

    <p>Clinical evidence of the drug's efficacy and safety</p> Signup and view all the answers

    Which of the following is NOT a component of the Quality Assurance system in pharmaceutical manufacturing?

    <p>Good Clinical Practice (GCP)</p> Signup and view all the answers

    What is the purpose of regulatory authorities such as the FDA and EMA?

    <p>To ensure only safe and effective drugs are marketed</p> Signup and view all the answers

    Which document is essential for pharmaceuticals to obtain a marketing authorisation?

    <p>Product license application</p> Signup and view all the answers

    What do pharmacopoeias provide for pharmaceutical products?

    <p>Standards for finished products and raw materials</p> Signup and view all the answers

    Which organization is responsible for inspecting pharmaceutical manufacturers to ensure compliance with regulations?

    <p>Competent authorities</p> Signup and view all the answers

    What is the primary focus of understanding the mechanism of degradation products in pharmaceuticals?

    <p>To predict shelf life</p> Signup and view all the answers

    Which of the following practices does NOT contribute to quality in pharmaceutical manufacturing?

    <p>Manufacturing without standards</p> Signup and view all the answers

    What is a common characteristic of counterfeit medicines?

    <p>They can have excessive amounts of active ingredients.</p> Signup and view all the answers

    What was the significant issue with the counterfeit Avastin reported in 2012?

    <p>It lacked any active ingredient.</p> Signup and view all the answers

    Which of the following is a potential indicator of a counterfeit drug?

    <p>Spelling mistakes on the packaging.</p> Signup and view all the answers

    What did the FDA find in the counterfeit version of Alli during preliminary tests?

    <p>It contained sibutramine instead of orlistat.</p> Signup and view all the answers

    Why is it important to verify the appearance of a drug?

    <p>Counterfeit drugs may have distinguishing features.</p> Signup and view all the answers

    What is one of the health risks associated with counterfeit medications?

    <p>They can cause adverse effects due to unknown ingredients.</p> Signup and view all the answers

    Which of the following packaging features might help identify a counterfeit medication?

    <p>Presence of a holographic seal.</p> Signup and view all the answers

    How can counterfeit packaging appear misleading?

    <p>It lacks a proper expiration date.</p> Signup and view all the answers

    What is the primary action of Orlistat in the treatment of obesity?

    <p>Prevents the absorption of fats</p> Signup and view all the answers

    What significant risk is associated with the use of Orlistat?

    <p>Increased risk of strokes</p> Signup and view all the answers

    What percentage of patients experienced cardiovascular events while using Sibutramine?

    <p>11.4%</p> Signup and view all the answers

    Why was Sibutramine withdrawn from the market?

    <p>Increased risk of cardiovascular events</p> Signup and view all the answers

    Which analytical technique is NOT mentioned for identifying active pharmaceutical ingredients?

    <p>Thin Layer Chromatography (TLC)</p> Signup and view all the answers

    What type of drug is Orlistat categorized as?

    <p>Centrally-acting anti-obesity drug</p> Signup and view all the answers

    What is one of the unpleasant effects associated with Sibutramine?

    <p>Gastrointestinal side effects</p> Signup and view all the answers

    Which method is employed for physical analysis of pharmaceutical products?

    <p>Particle size analysis</p> Signup and view all the answers

    Study Notes

    Introduction to Pharmaceutical Analysis

    • Pharmaceutical research and development often takes 12 years and costs around £500 million.

    • A drug's journey from research and development to market launch involves numerous stages:

      • Library screening
      • Hit to lead stage
      • Lead to candidate stage
      • Candidate selection
      • Clinical trials (Phase I to III)
      • File and launch

    Research & Development

    • Analytical techniques are critical in each stage of pharmaceutical research and development.

    • Analytical techniques evaluate the structure, purity, stability and properties of compounds:

      • Are the structures correctly identified?
      • How stable are the compounds over time?
      • Analysis of degradation products to understand mechanisms of degradation

    Obtaining a Marketing Authorization

    • A product license is required for all drugs, and it is a comprehensive documentation containing:
      • Clinical evidence demonstrating the drug's effectiveness and safety
      • Description of the manufacturing process
      • Data from studies supporting the quality, purity and shelf life of the drug

    Manufacture Authorization

    • All pharmaceutical companies require manufacture authorization.
    • This ensures only authorized manufacturers produce licensed products.
    • Authorities conduct regular inspections to ensure compliance with good manufacturing practices (GMP), quality assurance (QA), good laboratory practices (GLP), and quality control (QC).

    Pharmacopoeias

    • Published standards (monographs) for pharmaceutical products and raw materials.
    • Examples:
      • European Pharmacopoeia (Ph.Eur.)
      • United States Pharmacopoeia (USP)
      • British Pharmacopoeia (BP)

    Pharmacopoeia Guidelines

    • Outline requirements for:
      • Purity of raw materials (standards)
      • Methods for controlling raw materials
      • Pharmaceutical formulations (dosage forms)
      • Finished preparations (e.g., vaccines)

    Questions regarding Marketed Drugs

    • Analytical techniques evaluate:
      • Quality of each batch
      • Continuity of supply
      • Patent protection
      • Counterfeiting
      • Customer complaints regarding quality or effectiveness
      • Patient safety concerns

    Counterfeiting – Key facts

    • Counterfeit medicine is deliberately mislabeled with respect to identity or source.
    • Counterfeiting can lead:
      • Treatment failure
      • Death
      • Erosion of public confidence in healthcare systems
    • Both generic and branded medicines are subject to counterfeiting.
    • All kinds of drugs have been counterfeited.

    Counterfeiting – Mislabeling

    • Counterfeiting can involve:
      • Use of correct ingredients, wrong ingredients, or no active ingredients
      • Insufficient or excessive active ingredients
      • Fake packaging

    Counterfeit Drug Examples

    • Avastin (cancer treatment):

      • Counterfeit batches lacked the active ingredient

    • Alli (weight-loss medicine):

      • Counterfeit batches were smuggled and contained undeclared active ingredients
      • These undeclared ingredients posed serious health risks to consumers

    Identifying Counterfeit Drugs

    • Package and appearance help to identify counterfeit drugs:
      • Misspelling or missing LOT codes
      • Irregular expiration dates
      • Incorrect pill color or markings
      • Presence of powder instead of pellets in capsules

    Analysis Techniques for Counterfeiting

    • Visual Inspection: Analyzing packaging and tablets with microscopes.

    • Chemical Analysis:

      • Identifies the presence/absence of active pharmaceutical ingredients using:
        • Mass spectrometry (MS)
        • Nuclear magnetic resonance (NMR)
        • Infrared spectroscopy (IR)
      • Identifies excipients in formulations using:
        • MS, NMR, IR
      • Elemental mapping on tablet surfaces

    • Physical Analysis:

      • Measures particle size.

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    Related Documents

    Fundamentals of Analytical Chemistry (FAC) Introduction to Pharmaceutical Analysis PDF

    Description

    This quiz covers the essential aspects of pharmaceutical analysis in drug development. Delve into the stages of research and development and understand the analytical techniques critical for ensuring drug efficacy and safety. Learn about the importance of marketing authorization in bringing drugs to market.

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