During the early 1940s, microorganisms were employed to determine the presence and quantity of many antimicrobial agents, and more recently, to assess the mutagenicity of chemicals. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. This article is cited by 6 publications. Nontherapeutic equivalence of a generic product of imipenem-cilastatin is caused more by chemical instability of the active pharmaceutical ingredient (imipenem) than by its substandard amount of cilastatin. Drug Saf. can purchase separate chapters directly from the table of contents J Clin Pharmacol. 2020 Jul 16;11:703. doi: 10.3389/fgene.2020.00703. Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. The selection of microorganisms that can be used as a reagent is important to the success of any microbiological assay. Title:Development and Validation of Microbiological Assay for Ceftriaxone and its Application in Photo-stability Study VOLUME: 9 ISSUE: 1 Author(s):Felipe Rebello Lourenco, Marcus Augusto Lyrio Traple, Rogerio Takao Okamoto and Terezinha de Jesus Andreoli Pinto Affiliation:Departamento de Farmacia, Faculdade de Ciencias Farmaceuticas, Universidade de Sao Paulo – Av. A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide. Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics Abstract. Multisource drugs: implications and concerns in the geriatric population. Antimicrob Agents Chemother. The validation method yielded excellent results for linearity (r(2) > or = 0.98), precision (intra-assay variation < or = 11%; inter-assay variation < or = 10%), accuracy, and specificity tests according to international pharmacopoeial requirements. 1986;26:307–308. Immunology Applications. Lateral flow immunoassays used in clinical microbiology laboratories are usually double-antibody sandwich assays. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Mark every cup with proper dilution and keep the plates at low temperature (around 10°C) for 10-20 minutes for diffusion. 1993;28:96–2. For the detection of antigens, the capture zone (test line) on the membrane contains immobilized antibodies. NIH Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics Andres F Zuluaga 1,2 , Maria Agudelo 1 , Carlos A Rodriguez 1,2 and Potency estimates were 99.8 to 100.5, 99.7 to 100.2 and 98.5 to 99.9% for generic products of amikacin, gentamicin and vancomycin, respectively. As to date, the 2D- or 3D-assay methods represent the commonest and widely accepted form of the microbiological assay. Application of standard and Test Dilutions : With the help sterile micropipette tips apply 100 µl of different dilution to different cups. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and a statistical method to assess the in vitro equivalence of generic products with respect to the innovator. Background: E.g. eCollection 2020. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. https://doi.org/10.1016/B978-0-12-346445-3.X5001-6. J Pharm Anal. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays. -, Dettelbach HR. COVID-19 is an emerging, rapidly evolving situation. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. Genre/Form: Electronic books: Additional Physical Format: Print version: Hewitt, William, 1923-Theory and application of microbiological assay. Other chapters explore the various aspects of agar diffusion assays, tube assays, and diffusion assays. assay A quantitative or qualitative procedure for detecting the presence, estimating the concentration, and/or determining the biological activity* of a macromolecule (e.g., an antibody or antigen, molecule, ion, cell, pathogen, etc.). Generic vancomycin products fail in vivo despite being pharmaceutical equivalents of the innovator. Quality Control of Pharmaceuticals, Cheltenham, England, Pharmaceutical Microbiology, Glaxo Group Research, Greenford, England. In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin. Please enable it to take advantage of the complete set of features! HHS 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. Copyright © 1989 Elsevier Inc. All rights reserved. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Clipboard, Search History, and several other advanced features are temporarily unavailable. The principles are discussed by Roberts and Boyce. 0123464455 - Theory and Application of Microbiological Assay by Hewitt, William; Vincent, Stephen - AbeBooks Using the wrong microorganism, especially those that cannot be used as a reagent will result in the failure of the assay. Dafale NA, Semwal UP, Agarwal PK, Sharma P, Singh GN. J Pharm Anal. Latex agglutination. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and … Reference Id: PHARMATUTOR-ART-1560 Among the earliest applications of microbiological assays were those for vitamins and later for amino acids. Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations. Cosgrove RF, Beezer AE, Miles RJ. This site needs JavaScript to work properly. Mer M, Snyman JR, van Rensburg CE, van Tonder JJ, Laurens I. Clin Pharmacol. Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms. Zhu Z, Peng Q, Man Y, Li Z, Zhou X, Bai L, Peng D. Front Genet. The book further looks into the quality control procedures, assay design and evaluation, and assay replication. You currently don’t have access to this book, however you Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and... Background. A time to speak out on bioequivalence and therapeutic equivalence. The assay is based on the concentration-dependent variation of the inhibitory effect of antibiotics on reference bacteria (B. subtilis ATCC 6633, S. aureus ATCC 6538p and S. epidermidis ATCC 12228) in a seeded agar (Difco Antibiotic Media), producing a concentration-response linear relationship with two parameters: y-intercept (concentration) and slope (potency). Vesga O, Agudelo M, Salazar BE, Rodriguez CA, Zuluaga AF. Epub 2016 May 24. Antimicrob Agents Chemother. eCollection 2016. Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance. Microbiological assay required for the assay of a number of antibiotics, in both the British Microbes used as reagents in microbiological assays may be called microbial reagents. The fluid then migrates to the conjugate pad, which contains conjugated antibodies (conjugated with gold, colored latex, or a chromophore) directed … USA.gov. Applied and Environmental Microbiology ® (AEM) publishes study results that make significant contributions to applied microbial research, basic microbial ecology research, and genetic and molecular investigations of microbial topics of practical value.  |  (6) ‘Random Patterns’ for Application in Microbiological Plate Assay : In usual practice, we frequently come across two prevalent types ‘random patterns’ for application in the microbiological plate assay, namely : (a) Latin-Square Arrangement – in this particular case the number of replicates almost equals Dafale NA, Semwal UP, Rajput RK, Singh GN. Perspectives on generic pharmaceuticals: some conclusions. Rodriguez CA, Agudelo M, Zuluaga AF, Vesga O. BMC Infect Dis. Arrowhead Publishers; 2007. pp. Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. 2009 Sep;25(9):2179-89. doi: 10.1185/03007990903116867. This test is performed by binding antibodies or antigens to the surface of an artificial carrier called latex beads, such as polystyrene. H. V. Malmstadt and T. P. Hadjiioannou. eCollection 2019. Performing competitive assays by amplifying serial dilutions of the target DNA with and without the internal control should reveal if the sensitivity of the assay is affected ( 501 ). Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. We compared the parameters of 22 generic products (amikacin 4, gentamicin 15, and vancomycin 3 products) against the innovator and the reference powder by Overall Test for Coincidence of the Regression Lines (Graphpad Prism 5.0). ELISA is an antigen antibody reaction. Accumulation of data and computation of potencies were made by an on-line computer. Theory And Application Of Microbiological Assay book. Theory and Application of Microbiological Assay by Hewitt, William and a great selection of related books, art and collectibles available now at AbeBooks.com. ABSTRACT The microbiological assay of an antibiotic is based upon a comparison of the inhibition of growth of micro-organisms by measured concentrations of the antibiotics under examination with that produced by known concentrations of a standard preparation of the antibiotic having a known activity. Results: This book will serve as an introduction to newcomers to the field and as a reference source for established workers in microbiological assay. J Am Pharm Assoc (Wash) 2001;41:826–828. Search for: Diagnostic Immunology ... Precipitation assays are performed in semi-solid media such as agar or agarose where antibodies and antigens can diffuse toward one another and form a visible line of precipitation. 2010 Aug;54(8):3271-9. doi: 10.1128/AAC.01044-09. San Diego : Academic Press, ©1989 Boundless Microbiology. 2016 Aug;6(4):207-213. doi: 10.1016/j.jpha.2016.05.006. Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics doi: 10.1371/journal.pone.0211096. MICROBIOLOGICAL ASSAY: AN OVERVIEW; 1.1 Introduction; 1.2 General Principles of Biological Assay; 1.3 Basic Techniques of Microbiological Assay; 1.4 Capability and Limitations; 1.5 Current Status of Antibiotic Assays; 1.6 When to Use Microbiological Assays; References; CHAPTER 2. Methods: Physicochemical methods are preferred instead of biological assays to determine concentration of drugs in biological fluids, but it does not permit direct quantification of potency. The application of cryobiology to the microbiological assay of nystatin. Agudelo M, Rodriguez CA, Zuluaga AF, Vesga O. PLoS One. 2010 Jun 4;10:153. doi: 10.1186/1471-2334-10-153. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Improvements in the reproducibility of nystatin agar diffusion assays have been achieved by the use of liquid nitrogen stored inocula and deep frozen standard stock solutions. 1990;5 Suppl 1:114-9. doi: 10.2165/00002018-199000051-00018. The proposed method allows rapid, cost-saving, precise, and accurate determination of pharmaceutical equivalence of drugs in pharmaceutical dosage-form, and may be used as a technique for testing generic antibiotics prior to their approval for human use. The rate of growth of a species of microorganism that requires a vitamin is measured in growth media that contain various known quantities of a foodstuff preparation containing unknown amounts of the vitamin. Specific Enzymatic Determination of Some Alpha-Amino Acids by an Automatic Spectrophotometric Reaction Rate Method.. AbeBooks.com: Theory and Application of Microbiological Assay (9780123464453) by Hewitt, William; Vincent, Stephen and a great selection of similar New, Used and Collectible Books available now at … Description. antibiotic assay media are used for determining antibiotic potency by the microbiological assay technique. Application: Used for blood typing or Blood Grouping. 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 theory and application of theory and By continuing you agree to the use of cookies. Epub 2014 Jul 21. Assay media. Kavanagh F. Application of new equipment and new techniques was made to antibiotic diffusion assays. Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. Hosp Pharm. Microbiological assay is a technique in which the potency or concentration of a compound is assessed by determining its effect on micro-organisms. http://www.arrowheadpublishers.com/reports/infectious-disease/the-global... http://www.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf, The Global Antibacterials Market: R&D Pipelines, Market Analysis and Competitive Landscape. 2016 Nov 17;8:191-198. doi: 10.2147/CPAA.S106676. In 1971, ELISA was introduced by Peter Perlmann and Eva Engvall at Stockholm University in Sweden. Read 2 reviews from the world's largest community for readers. Description. We use cookies to help provide and enhance our service and tailor content and ads. The chapter accounts for the microbiological assay techniques for the determination of vitamins like thiamine, pantothenic acid, nicotinic acid and amide, biotin, inositol, vitamin B 6, folic acid, folinic acid, and vitamin B 12 in body fluids. Except for one generic of vancomycin that had 25% more API (P(y-intercept) = 0.001), the pharmaceutical equivalence was demonstrated in 21 generics with undistinguishable slopes and intercepts (P > 0.66). Copyright © 2021 Elsevier B.V. or its licensors or contributors. Assays are based on measurable parameters that allow differentiation between sample and control. -, Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generics) Products: A Manual for Drug Regulatory Authorities