Microbiological Assay for Pharmaceutical Analysis: A Rational ApproachA user-friendly guide for the evaluation of microbiological assays, this book 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. 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 expands on the guidance given in pharmacopoeias and helps readers choose the assay design most appropriate for the purpose of their assay. |
Contents
1 | |
Chapter 2 The Agar Diffusion Assay Its Quantitative Basis | 9 |
Chapter 3 The Theory and Practice of Tube Assays for GrowthPromoting Substances | 23 |
Chapter 4 The Theory and Practice of Tube Assays for GrowthInhibiting Substances | 37 |
Chapter 5 What Do We Want of an Assay? How Do We Attain Our Goal? | 59 |
Chapter 6 General Practical Aspects of Microbiological Assays | 65 |
Chapter 7 Standard Reference Materials | 79 |
Chapter 8 Preliminary Evaluation of Data | 89 |
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Microbiological Assay for Pharmaceutical Analysis: A Rational Approach William Hewitt No preview available - 2003 |
Common terms and phrases
agar diffusion assay analysis of variance antibiotic assay design Bacitracin benzylpenicillin bias biological assays Chapter column confidence limits corresponding degrees of freedom deviation squares dilution dose levels dose ratio Equation erythromycin estimated potency European Pharmacopoeia example Figure four-dose level growth growth-inhibiting substance Hewitt high-dose test solution illustrated incubation International Pharmacopoeia IU/ml kanamycin Latin square Latin square design limiting value log dose mean responses medium method microbiological assay neomycin obtained outlier parallel-line assays penicillin plotted polymyxin potency estimate potency ratio preparation procedure quadratic curvature range raw data reference standard replication residual error response lines S₁ sample slope ratio assays standard and unknown standard test solution statistical evaluation Step streptomycin symmetrical assay Table temperature test organism tetracycline treatment totals turbidimetric assay two-dose level assay United States Pharmacopoeia unknown test solution variance ratios weighings Width of Confidence zero dose zone diameter zone width µg/ml