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
| xiv | |
| xix | |
What Happens in Practice | xxvii |
Production of Acid by Lactobacilli | xli |
Factors Affecting Final Cell Count | lvi |
A Practically Determined Log DoseResponse Curve | lvii |
Problems with Very Dilute Solutions | lxix |
Standard Reference Materials | lxxvi |
ParallelLine Assays Some Designs and Their Evaluation | lxxxix |
Preliminary Inspection of Data | lxx |
Calculation of Potency Estimate from the Treatment Totals | lxxi |
Discussion of Assay Validity Based on the Analysis of Variance | lxxxv |
Preliminary Inspection of Data | xcix |
Evaluation of a TwoDose Level Assay Using the Bliss Procedure | cviii |
The Effect of the Value of M on Width of Confidence Limits | cxxii |
Concluding Thoughts | cxxxv |
Other editions - View all
Microbiological Assay for Pharmaceutical Analysis: A Rational Approach William Hewitt Limited preview - 2003 |
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 biological assays Chapter column confidence limits corresponding degrees of freedom dilution dose levels dose ratio erythromycin estimated potency European Pharmacopoeia example Figure generation-rate constant growth-inhibiting substance growth-promoting substances high-dose test solution illustrated incubation inhibition zones inoculated inoculum inoculum level International Pharmacopoeia kanamycin Latin square Latin square design limiting value linear log dose log dose-response line logarithm of dose mean responses microbiological assay neomycin obtained outlier parallel-line assays penicillin pipette polymyxin potency estimate precision preparation procedure range raw data reference standard regression replication residual error response lines sample shown slope ratio assays specific growth rate standard and unknown standard curve standard test solution Step streptomycin suspension symmetrical assay Table temperature test organism tetracycline treatment totals tube assay turbidimetric assay two-dose level assay United States Pharmacopoeia variance ratios weighing zero dose zone diameter zone width


