Microbiological Assay: A Rational Approach

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Overview

A user-friendly guide for the evaluation of microbiological assays, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. Beginning with a review of the theoretical basis for the quantitative aspects, the author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist.

The book contains detailed evaluations of assays that illustrate typical experimental designs and addresses how to present a realistic assessment of the best potency estimate from a series of assays. Although there are other valuable books available in this area, they do not address evaluation. Microbiological Assay for Pharmaceutical Analysis: A Rational Approach expands on the guidance given in pharmacopoeias and helps you choose the assay design most appropriate for the purpose of your assay.

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Product Details

  • ISBN-13: 9780849318245
  • Publisher: Taylor & Francis
  • Publication date: 6/28/2003
  • Pages: 260
  • Product dimensions: 6.00 (w) x 9.10 (h) x 0.90 (d)

Table of Contents

MICROBIOLOGICAL ASSAY IN PERSPECTIVE
Biological Assays in General
The Different Sorts of Microbiological Assay
The Basis of Calculation of Potency Estimates
Which Mathematical Model?

THE AGAR DIFFUSION ASSAY - ITS QUANTITATIVE BASIS
Historical Introduction
The Theory of Zone Formation
Principle of Calculation of Potency Estimate

THE THEORY AND PRACTICE OF TUBE ASSAYS FOR GROWTH PROMOTING SUBSTANCES
Introduction
The Mode of Action
Critical Factors in the Assay of Growth-Promoting Substances
Other Sources of Error

THE THEORY AND PRACTICE OF TUBE ASSAYS FOR GROWTH INHIBITING SUBSTANCES
Historical Introduction
Measurement of Response
The Form of Response Line
Historical Development of the Turbidimetric Method
Linearization of Sigmoid Curves
The Quantitative Theory of Microbial Inhibition
A Practically Determined Log Dose-Response Curve
Factors Affecting Final Cell Count
Summary and Conclusions

WHAT DO WE WANT OF AN ASSAY? HOW DO WE ATTAIN OUR GOAL?
Introduction
Pharmacopoeial Intention
Control of Antibiotic Bulk Materials
Control in Routine Manufacture
Research and Development

GENERAL PRACTICAL ASPECTS OF MICROBIOLOGICAL ASSAYS
Introduction
Inoculum
Test Solutions
Weighing
The Assay Medium
Selection of Latin Squares and the Plating Routine
Aseptic Techniques
Measuring Responses
Calculation of Potency Estimates and Confidence Limits

STANDARD REFERENCE MATERIALS
Historical Introduction
"Official" Reference Materials
National and Regional Reference Materials
In-House Standards

PRELIMINARY EVALUATION OF DATA
Introduction
Common Sense Inspection
Specific Tests for Abnormality
Detection of Outliers
Replacement of Missing Values
Summary and Conclusions

PARALLEL LINES ASSAYS - SOME DESIGNS AND THEIR EVALUATION
Introduction
A 3-Dose Level Assay Using Petri Dishes
A 3-Dose Level Assay for One Unknown Using a Large Plate and Latin Square Design
A 2-Dose Level Assay for Four Preparations [three unknowns] Using a Large Plate and 8 x 8 Latin Square Design
A 2-Dose Level Assay for Two Preparations [one unknown] Using a Large Plate and 8 x 8 Latin Square Design with Two Weighings of Each Preparation
A 4-Dose Level Turbidimetric Assay for One Unknown
A Small Plate Assay Using a 5-Dose Level Standard Curve

SLOPE RATIO ASSAYS, SOME DESIGNS AND THEIR EVALUATION
Introduction
Some Possible Designs
Preliminary Evaluation
General Statistical Procedures
The Procedure of Bliss
Evaluation of a 2-Dose Level Assay (1) Using the Bliss Procedure (2) The Procedure of the European Pharmacopoeia

CHOICE OF EXPERIMENTAL DESIGN
Introduction
Available Experimental Designs for Agar Diffusion Assays
Regulations and Options
Factors Influencing Width of Confidence Limits
Bias Due to Curvature of the Response Line
Non-Paralellism Due to Curvature
Choosing a Design for a Turbidimetric Growth Inhibiting Substance Assay
Choosing a Design for Turbidimetric Assay of Growth Promoting Substance
Summary and Conclusions

CONCLUDING THOUGHTS
Introduction
Calculation of a Weighted Mean Based on Internal Assay Variation
Comparison of the European and International Pharmacopoeia Methods
Application of the Various Formulae to Some Practical Results

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