Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms. Methods: Quality Control of Pharmaceuticals, Cheltenham, England, Pharmaceutical Microbiology, Glaxo Group Research, Greenford, England. Hosp Pharm. Description. COVID-19 is an emerging, rapidly evolving situation. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and … Copyright © 1989 Elsevier Inc. All rights reserved. Microbiological assay is a technique in which the potency or concentration of a compound is assessed by determining its effect on micro-organisms. USA.gov. 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).  |  Conclusion: Mer M, Snyman JR, van Rensburg CE, van Tonder JJ, Laurens I. Clin Pharmacol. 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. Used for the quantification of virus dilutions in a haemagglutination assay. This article is cited by 6 publications. Epub 2014 Jul 21. https://doi.org/10.1016/B978-0-12-346445-3.X5001-6. The principles are discussed by Roberts and Boyce. Cosgrove RF, Beezer AE, Miles RJ. 1993;28:96–2. The book further looks into the quality control procedures, assay design and evaluation, and assay replication. For the detection of antigens, the capture zone (test line) on the membrane contains immobilized antibodies. Epub 2010 Jun 14. Curr Med Res Opin. Theory and Application of Microbiological Assay by Hewitt, William and a great selection of related books, art and collectibles available now at AbeBooks.com. We use cookies to help provide and enhance our service and tailor content and ads.  |  Background: Kavanagh F. Application of new equipment and new techniques was made to antibiotic diffusion assays. See this image and copyright information in PMC. 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). 2016 Aug;6(4):207-213. doi: 10.1016/j.jpha.2016.05.006. 2009 Sep;25(9):2179-89. doi: 10.1185/03007990903116867. Other types of medium include; Media for enumeration of bacteria, Media for characterization of bacteria, Maintenance media etc. Accumulation of data and computation of potencies were made by an on-line computer. 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. 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 … Clipboard, Search History, and several other advanced features are temporarily unavailable. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. -, Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generics) Products: A Manual for Drug Regulatory Authorities or = 0.98), precision (intra-assay variation < or = 11%; inter-assay variation < or = 10%), accuracy, and specificity tests according to international pharmacopoeial requirements. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays. Antimicrob Agents Chemother. 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. In 1971, ELISA was introduced by Peter Perlmann and Eva Engvall at Stockholm University in Sweden. As to date, the 2D- or 3D-assay methods represent the commonest and widely accepted form of the microbiological assay. Perspectives on generic pharmaceuticals: some conclusions. Dafale NA, Semwal UP, Agarwal PK, Sharma P, Singh GN. Assay media. Therapeutic equivalence requires pharmaceutical, pharmacokinetic, and pharmacodynamic identities: true bioequivalence of a generic product of intravenous metronidazole. Application: Used for blood typing or Blood Grouping. Drug Saf. -, Dettelbach HR. 2019 Feb 6;14(2):e0211096. Mark every cup with proper dilution and keep the plates at low temperature (around 10°C) for 10-20 minutes for diffusion. It is a common laboratory technique which is usually used to measure the concentration of antibodies or antigens in blood. In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin. Microbes used as reagents in microbiological assays may be called microbial reagents. J Pharm Anal. 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 ). 2015 Feb;5(1):18-26. doi: 10.1016/j.jpha.2014.07.007. E.g. Specific Enzymatic Determination of Some Alpha-Amino Acids by an Automatic Spectrophotometric Reaction Rate Method.. 2010 Aug;54(8):3271-9. doi: 10.1128/AAC.01044-09. Other articles where Microbiological assay is discussed: vitamin: Microbiological assay: Microbiological assay is applicable only to the B vitamins. Immunology Applications. doi: 10.1371/journal.pone.0211096. 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). NIH A time to speak out on bioequivalence and therapeutic equivalence. The fluid then migrates to the conjugate pad, which contains conjugated antibodies (conjugated with gold, colored latex, or a chromophore) directed … A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide. ELISA- Principle, Types and Applications. Theory And Application Of Microbiological Assay book. Lateral flow immunoassays used in clinical microbiology laboratories are usually double-antibody sandwich assays. 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