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. 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. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and … ELISA- Principle, Types and Applications. These media are used for the assay of vitamins, amino acids, and antibiotics. 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 … 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 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. Cosgrove RF, Beezer AE, Miles RJ. Therapeutic equivalence requires pharmaceutical, pharmacokinetic, and pharmacodynamic identities: true bioequivalence of a generic product of intravenous metronidazole. 2009 Sep;25(9):2179-89. doi: 10.1185/03007990903116867. HHS The fluid then migrates to the conjugate pad, which contains conjugated antibodies (conjugated with gold, colored latex, or a chromophore) directed … Other articles where Microbiological assay is discussed: vitamin: Microbiological assay: Microbiological assay is applicable only to the B vitamins. 0123464455 - Theory and Application of Microbiological Assay by Hewitt, William; Vincent, Stephen - AbeBooks J Pharm Anal. https://doi.org/10.1016/B978-0-12-346445-3.X5001-6. 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. Other chapters explore the various aspects of agar diffusion assays, tube assays, and diffusion assays. H. V. Malmstadt and T. P. Hadjiioannou. 1986;26:307–308. Real-time PCR assays used in microbiology require optimal sensitivity and the use of internal controls should not decrease the sensitivity of the assay. 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 ). eCollection 2019. 2010 Jun 4;10:153. doi: 10.1186/1471-2334-10-153. Theory and Application of Microbiological Assay by Hewitt, William and a great selection of related books, art and collectibles available now at AbeBooks.com. Read 2 reviews from the world's largest community for readers. or buy the full version. antibiotic assay media are used for determining antibiotic potency by the microbiological assay technique. For the detection of antigens, the capture zone (test line) on the membrane contains immobilized antibodies. 2015 Feb;5(1):18-26. doi: 10.1016/j.jpha.2014.07.007. 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. Lateral flow immunoassays used in clinical microbiology laboratories are usually double-antibody sandwich assays. -, Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generics) Products: A Manual for Drug Regulatory Authorities