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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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Inside This Book
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First Sentence:
There are many types of biological tests, but for our purpose, a biological assay is defined as "a practical procedure whereby the potency of a material of unknown potency (the unknown) is estimated by comparison of its effect in a biological system with that of a reference standard of known or defined potency." Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
neomycin activity, arbitrary probability level, symmetrical assays, kanamycin base, relative cell concentration, nominal potencies, pharmacopoeia guidance, pharmacopoeial guidance, mean log dose, unknown test solution, cubic curvature, nominal dose levels, nominal potency, concerning variance ratios, duplicate weighings, unscrambled data, level standard curve, potency estimate, standard test solution, estimated potency, agar diffusion assay, collaborative assay, slope ratio assays, turbidimetric assay, regression squares Key Phrases - Capitalized Phrases (CAPs): (learn more)
European Pharmacopoeia, Academic Press, Discussion of Assay Validity Based, International Pharmacopoeia, Squares Squares Ratio Value Level, New York, Council of Europe, Probability Preparations, San Diego, Statistical Evaluation Step, Biological Standardization, Code of Federal Regulations, European Union, Expert Committee, Logarithm of Known Potency Ratio, Preliminary Inspection of Data Referring, Logarithm of Streptomycin Concentration New!
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Front Cover | Table of Contents | First Pages | Index | Surprise Me!
There are many types of biological tests, but for our purpose, a biological assay is defined as "a practical procedure whereby the potency of a material of unknown potency (the unknown) is estimated by comparison of its effect in a biological system with that of a reference standard of known or defined potency." Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
neomycin activity, arbitrary probability level, symmetrical assays, kanamycin base, relative cell concentration, nominal potencies, pharmacopoeia guidance, pharmacopoeial guidance, mean log dose, unknown test solution, cubic curvature, nominal dose levels, nominal potency, concerning variance ratios, duplicate weighings, unscrambled data, level standard curve, potency estimate, standard test solution, estimated potency, agar diffusion assay, collaborative assay, slope ratio assays, turbidimetric assay, regression squares Key Phrases - Capitalized Phrases (CAPs): (learn more)
European Pharmacopoeia, Academic Press, Discussion of Assay Validity Based, International Pharmacopoeia, Squares Squares Ratio Value Level, New York, Council of Europe, Probability Preparations, San Diego, Statistical Evaluation Step, Biological Standardization, Code of Federal Regulations, European Union, Expert Committee, Logarithm of Known Potency Ratio, Preliminary Inspection of Data Referring, Logarithm of Streptomycin Concentration New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
Citations (learn more)
This book cites 4
books:
- Theory and Application of Microbiological Assay by William Hewitt on 5 pages
- Statistical Method in Biological Assay by David John Finney on page 36, and page 168
- The International Pharmacopoeia (Volume 2) by World Health Organization in Back Matter
- Contract Manufacturing by Leadership Inc. in Front Matter
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