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A 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.
Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. Some chapters discuss the test organisms and solutions, wherein test solutions are the final dilutions at a series of two or more concentrations that have been prepared from reference standard and unknown for application to the test system. Other chapters explore the various aspects of agar diffusion assays, tube assays, and diffusion assays. The book further looks into the quality control procedures, assay design and evaluation, and assay replication. This book will serve as an introduction to newcomers to the field and as a reference source for established workers in microbiological assay.
Analytical Microbiology focuses on the processes, methodologies, developments, and approaches involved in analytical microbiology, including microbiological, antibiotic, and amino acid assays and dilution methods. The selection first offers information on the theory of antibiotic inhibition zones, microbiological assay using large plate methods, and dilution methods of antibiotic assays. Discussions focus on serial dilution assay, requirements for accurate assay, microbiological assay of riboflavin, laws of adsorption and partition, mechanisms of antibiotic action, and biological considerations affecting the use of statistical methods. The text then ponders on the elements of photometric assaying and automation of microbiological assays. The manuscript elaborates on antibiotic substances, vitamins, and amino acids. Topics include assay organisms, validity, specificity, reliability, and calculation of results of amino acid assays, bacitracin, chloramphenicol, dihydrostreptomycin, erythromycin, neomycin, and streptomycin. The selection is a dependable reference for researchers interested in analytical microbiology.
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
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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Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks