Bioassay Technique
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Questions and Answers

What is the primary difference between direct and indirect bioassays?

  • Direct bioassays measure the pharmacological activity of a drug, while indirect bioassays measure the chemical structure. (correct)
  • Direct bioassays are more precise, while indirect bioassays are less precise.
  • Direct bioassays are used for chemical assays, while indirect bioassays are used for bioassays.
  • Direct bioassays are based on quantitative responses, while indirect bioassays are based on qualititative responses.
  • When is chemical assay preferred over bioassay?

  • When the drug is sensitive to low doses.
  • When the active principle of the drug is not known.
  • When the chemical structure of the drug is fully known. (correct)
  • When the biological activity of the drug cannot be defined by a chemical assay.
  • What is the purpose of bioassay in the standardization of drugs obtained from natural sources?

  • To isolate the active principle of the drug.
  • To determine the pharmacological activity of the drug.
  • To determine the chemical structure of the drug.
  • To compare the strength of the drug from various sources. (correct)
  • What is the purpose of comparing a test substance with the International Standard preparation?

    <p>To standardize the drug.</p> Signup and view all the answers

    Why is bioassay used to measure the pharmacological activity of peptide hormones?

    <p>Because peptide hormones cannot be purified.</p> Signup and view all the answers

    What is the advantage of bioassay over chemical assay in certain situations?

    <p>Bioassay can measure the pharmacological activity of a drug when the chemical structure is unknown.</p> Signup and view all the answers

    What is the primary objective of bioassay?

    <p>To determine the potency of a test substance</p> Signup and view all the answers

    What is the characteristic of a quantal bioassay?

    <p>An all-or-none response is observed</p> Signup and view all the answers

    What is the purpose of using a standard preparation in bioassay?

    <p>To provide a reference point for comparison</p> Signup and view all the answers

    What is the acceptable limit of accuracy in bioassay?

    <p>± 20% of true value</p> Signup and view all the answers

    What is the characteristic of a graded bioassay?

    <p>A graded response is observed</p> Signup and view all the answers

    What is the purpose of minimizing biological variation in bioassay?

    <p>To reduce the error in the measurement</p> Signup and view all the answers

    What is the primary role of pharmacists?

    <p>To serve as a source of therapeutic substances and provide information about their use and actions</p> Signup and view all the answers

    What has evolved over time in the concept of drug quality?

    <p>Simple checks of the final product</p> Signup and view all the answers

    What is one of the responsibilities of pharmacists?

    <p>To ensure the quality of a drug</p> Signup and view all the answers

    What is a key aspect of drug quality assurance?

    <p>Ensuring the stability of a drug</p> Signup and view all the answers

    What is a type of test used to evaluate the quality of a drug?

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

    What is the goal of pharmaceutical assays?

    <p>To ensure the quality of a drug</p> Signup and view all the answers

    Study Notes

    Types of Bioassays

    • Direct assays
    • Indirect assays:
      • Based on quantitative responses (Graded)
      • Based on quantal responses (“all or none”; Quantal)

    Comparison of Chemical and Bioassay

    • Bioassay:
      • Less precise
      • More time-consuming
      • Active constituent and structure not known
      • More sensitive
    • Chemical Assay:
      • More precise
      • Less time-consuming
      • Active constituent and structure fully known
      • Less sensitive

    Indications of Bioassay

    • Chemical method is not available or is too complex
    • Insensitive to low doses (e.g., Histamine)
    • Active principle cannot be isolated (e.g., insulin)
    • To measure the pharmacological activity of new or chemically undefined substances
    • Biological activity of drug cannot be defined by a chemical assay (e.g., Cis- and Trans- form of methyl phenidate)
    • To compare the strength of a drug obtained from various sources due to different compositions
    • Biological standardization of drugs obtained from natural sources

    Principles of Bioassay

    • Compare the test substance with the International Standard preparation
    • Determine how much test substance is required to produce the same biological effect
    • Activity assayed should be the activity of interest
    • Standard and test sample should have similar pharmacological effects and mode of action
    • Minimize biological variation by keeping experimental conditions constant

    Quantal Bioassay

    • All or none response in all individuals (e.g., Digitalis induced cardiac arrest in guinea pigs)
    • Not precise
    • Employed for: Comparison of LD50 and ED50

    Graded Bioassay

    • As the dose increases, there is an equivalent rise in response
    • Potency is estimated by comparing test sample responses with the standard response curve
    • Example: Acetylcholine producing contraction of smooth muscle of frog Rectus abdominis

    Accuracy Limits of Bioassay

    • Accuracy improves the efficiency of bioassay for pharmaceutical biological products
    • An accuracy within ± 20% of true value is good; within ± 10% is excellent

    Introduction to Concepts in Pharmaceutical Assays and Determination

    • Primary role of pharmacists is to serve as a source of therapeutic substances and provide information about their use and actions
    • Responsibilities of pharmacists include:
      • Assuring high-quality drugs in terms of chemical identity, purity, potency, stability, efficacy, safety, and acceptability

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    Description

    Learn about the bioassay technique used to compare the activity of a test substance to a standard substance. Understand the importance of similar pharmacological effects and mode of action. Discover how to minimize biological variation in experiments.

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