Bioanalysis 2012 Oct;4(19):2335-42
Bioanalysis 2021 Apr 13. Epub 2021 Apr 13.
CRMedicon, Piscataway, NJ, USA.
The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. While ICH M10 will cover requirements for reference standards, one of the biggest challenges facing the CRO community is the lack of consistency and completeness of Certificates of Analysis for reference standards used in regulated bioanalysis. Read More
Jpn J Nurs Sci 2021 Apr;18(2):e12396
Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Aim: To estimate diagnostic accuracy of ultrasonography for detecting aspiration and pharyngeal residue in patients with dysphagia.Methods: A systematic search was conducted in MEDLINE (via PubMed), CINAHL, EMBASE, Ichushi-Web, and Cochrane Library databases to identify articles that showed diagnostic accuracy of ultrasonography for detecting aspiration and residue published in English and Japanese until August 2019. Cross-sectional studies, case-control studies, and cohort studies were included. Read More
J Chem Educ 2020 Nov 26;97(11):3976-3983. Epub 2020 Oct 26.
Chemistry and Biochemistry Department, University of Notre Dame, Notre Dame, Indiana, USA, 46556.
The distributed pharmaceutical analysis laboratory (DPAL) is a collaboration between 30 academic institutions around the world, whose goal is to determine the quality of medicines collected from partner organizations in low- and middle-income countries (LMICs). Institutions complete system suitability for a high-performance liquid chromatography (HPLC) system using United States Pharmacopeia (USP)-traceable reference standards, and are then approved to analyze batches of samples that are collected in LMICs by covert shoppers. Open Science Framework (OSF) allows DPAL participants access to resources for the program including an HPLC methodology manual, a wiki with HPLC troubleshooting information, detailed checklists and Excel templates for system suitability and sample assay, as well as steps for reporting results. Read More
Nihon Shokakibyo Gakkai Zasshi 2021 ;118(4):318-326
Department of Medicine, Teikyo University School of Medicine.
Although standard treatment for autoimmune hepatitis (AIH) comprises prednisolone (PSL) and azathioprine (AZA), some patients are intolerant to or do not respond to PSL and/or AZA. The clinical practice guidelines of AIH in Europe and North America recommend mycophenolate mofetil (MMF) as second-line treatment in these patients. We administered MMF as second-line therapy to 7 patients with AIH (male/female 1/6, age range 27-79 years) who were intolerant to or failed to respond to standard treatment. Read More
Forensic Sci Int 2021 Mar 30;322:110771. Epub 2021 Mar 30.
Laboratoire de Pharmacologie - Toxicologie, Centre Hospitalier Universitaire Raymond Poincaré, FHU Sepsis, AP-HP, 104 boulevard Raymond Poincaré, 92380 Garches, France; Plateforme de Spectrométrie de Masse MassSpecLab, INSERM UMR 1173, UFR des Sciences de la Santé Simone Veil, Université Paris-Saclay (Versailles Saint-Quentin-en-Yvelines), 2 avenue de la source de la Bièvre, 78180 Montigny-le-Bretonneux, France. Electronic address:
Substandard/counterfeit drugs are a growing global problem. According to the World Health Organisation, counterfeit medicines are medicines that are mislabelled deliberately and fraudulently regarding their identity and/or source. In high income countries, drugs seized are mainly represented by performance and image enhancing drugs (PIEDs). Read More