ABBREVIATIONS. FDA, US Food and Drug Administration; NDA, new drug application; PDR, Physicians Desk Reference; NME, new molecular entity; AAP, American Academy of Pediatrics; COD, Committee on Drugs; OPD, orphan products development; USP, US Pharmacopeia; USP-DI, US Pharmacopoeia–Drug Information; PhRMA, Pharmaceutical Research and Manufacturers Association; NIH, National Institutes of Health;...

Eduardo Mekitarian Filho, Werther Brunow de Carvalho, Sérgio Cavalheiro, Nelson Kazunobu Horigoshi, Norberto Antonio Freddi, Gil Kruppa Vieira I Pediatrics and Sciences Applied to Pediatrics, Universidade Federal de São Paulo (UNIFESP), Pediatric Emergency Department, University Hospital of Universidade de São Paulo (USP) and Admissions Unit of Hospital Israelita Albert Einstein, Pediatric Inte...

The insect steroid hormone 20-hydroxyecdysone (20E) acts through a specific nuclear receptor complex, ecdysone receptor (EcR) and ultraspiracle (USP). EcR and USP are FXR/LXR and RXR orthologs, respectively, which play critical roles in the regulation of lipid metabolism in mammals. Lipid concentration in Bombyx hemolymph and lipase activity in fat body peaked during molting and pupation, sugge...

The antimicrobial effectiveness test first appeared as a USP General Chapter in the 18th revision, official September 1, 1970. This chapter, at the beginning, was designed to evaluate the performance of antimicrobials added to inhibit the growth of microorganisms that might be introduced during or subsequent to the manufacturing process. As Good Manufacturing Practices (GMPs) became a governing...

At intravenous dosages of ≥8 mcg/kg, sufentanil produces hypnosis and anesthesia without the use of additional anesthetic agents. A deep level of anesthesia is maintained at these dosages, as demonstrated by EEG patterns. Dosages of up to 25 mcg/kg attenuate the sympathetic response to surgical stress. The catecholamine response, particularly norepinephrine, is further attenuated at doses of su...

Standardized in-vitro dissolution testing of suppositories has been of interest to the pharmaceutical industry since the early works of Giabaldi and Gundhofer in 1975.(1) Anthony Palmieri exam ined standard izin g suppository dissolutions in his work at the University of Wyoming (2). Palmieri developed a slotted dissolution basket for suppositories that is ---------widely used by many individua...

with Communication Delays ASHU AHUJA, S. K. AGGARWAL 2 Electrical Engineering Department, Maharishi Markandeshwar University, Mullana, INDIA [email protected], [email protected] Abstract:The presence of communication delay in modern load frequency control (LFC) systems complicates the design and implementation of the controller to achieve robust performance of the system. In th...

Oleic acid is a common pharmaceutical excipient that has been widely used in various dosage forms. Gas chromatography (GC) has often been used as the quantitation method for fatty acids normally requiring a derivatization step. The aim of this study was to develop a simple, robust, and derivatization-free GC method that is suitable for routine analysis of all the major components in oleic acid ...

Trabalho realizado na Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo USP Ribeirão Preto (SP) Brasil. 1 Doutora, Professora da Faculdade de Ciências Médicas da Pontifícia Universidade Católica de Campinas PUC Campinas (SP) Brasil. 2 Doutor, Professor do Departamento de Clínica Médica da Faculdade de Ciências Médicas da Universidade Estadual de Campinas UNICAMP Campinas (SP)...

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that is widely used for the treatment of mild-to-moderate pain. Mefenamic acid belongs to the Biopharmaceutical Classification System (BCS) class II drug which has lower water solubility but high permeability. There are two different compendial methods available for dissolution tests of mefenamic acid solid dosage forms, i.e. meth...