Microbiological Assay Systems for the Analysis of Antibiotics in Pharmaceutical Formulations
Author: Gerard Michael Greco
Publisher:
Published: 1997
Total Pages: 414
ISBN-13:
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Author: Gerard Michael Greco
Publisher:
Published: 1997
Total Pages: 414
ISBN-13:
DOWNLOAD EBOOKAuthor: William Hewitt
Publisher: CRC Press
Published: 2003-12-15
Total Pages: 261
ISBN-13: 020350397X
DOWNLOAD EBOOKA 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.
Author: William Hewitt
Publisher: Elsevier
Published: 2012-12-02
Total Pages: 338
ISBN-13: 0323155286
DOWNLOAD EBOOKTheory 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.
Author: United States Food and Drug Administration
Publisher: Createspace Independent Publishing Platform
Published: 2017-09-21
Total Pages: 92
ISBN-13: 9781976578670
DOWNLOAD EBOOKManual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Author: Richard Schwalbe
Publisher: CRC Press
Published: 2007-05-22
Total Pages: 430
ISBN-13: 1420014498
DOWNLOAD EBOOKThe clinical microbiology laboratory is often a sentinel for the detection of drug resistant strains of microorganisms. Standardized protocols require continual scrutiny to detect emerging phenotypic resistance patterns. The timely notification of clinicians with susceptibility results can initiate the alteration of antimicrobial chemotherapy and
Author: Jun Lin
Publisher: Frontiers Media SA
Published: 2015-06-01
Total Pages: 226
ISBN-13: 2889195260
DOWNLOAD EBOOKAntibiotics represent one of the most successful forms of therapy in medicine. But the efficiency of antibiotics is compromised by the growing number of antibiotic-resistant pathogens. Antibiotic resistance, which is implicated in elevated morbidity and mortality rates as well as in the increased treatment costs, is considered to be one of the major global public health threats (www.who.int/drugresistance/en/) and the magnitude of the problem recently prompted a number of international and national bodies to take actions to protect the public (http://ec.europa.eu/dgs/health_consumer/docs/road-map-amr_en.pdf: http://www.who.int/drugresistance/amr_global_action_plan/en/; http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf). Understanding the mechanisms by which bacteria successfully defend themselves against the antibiotic assault represent the main theme of this eBook published as a Research Topic in Frontiers in Microbiology, section of Antimicrobials, Resistance, and Chemotherapy. The articles in the eBook update the reader on various aspects and mechanisms of antibiotic resistance. A better understanding of these mechanisms should facilitate the development of means to potentiate the efficacy and increase the lifespan of antibiotics while minimizing the emergence of antibiotic resistance among pathogens.
Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
Published: 1969
Total Pages: 180
ISBN-13:
DOWNLOAD EBOOKAuthor: Estée Török
Publisher: Oxford University Press
Published: 2017
Total Pages: 914
ISBN-13: 019967132X
DOWNLOAD EBOOKThis handbook takes an integrated approach to both infectious disease and microbiology. Referenced to national frameworks and current legislation, it covers basic principles of bacteriology and virology, specific information on diseases and conditions, and material on 'hot topics' such as bioterrorism and preventative medicine.
Author: Atta-ur-Rahman
Publisher: CRC Press
Published: 2001-10-04
Total Pages: 214
ISBN-13: 1135287228
DOWNLOAD EBOOKThe goal of an activity-directed isolation process is to isolate bioactive compounds which may provide structural leads of therapeutic importance. Whereas the traditional process of drug development is long and expensive, simple and rapid bioassays can serve as the starting point for drug discovery. This book presents a range of "bench top" bioassa
Author: United States. Food Safety and Inspection Service. Microbiology Division
Publisher:
Published: 1998
Total Pages: 634
ISBN-13:
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