Microbiological Assay for Pharmaceutical Analysis: A Rational Approach, 1st Edition (Hardback) book cover

Microbiological Assay for Pharmaceutical Analysis

A Rational Approach, 1st Edition

By William Hewitt

CRC Press

260 pages | 49 B/W Illus.

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pub: 2003-12-15
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Description

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.

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI045000
SCIENCE / Life Sciences / Biology / Microbiology