Abstract：
:After assay validation in an originating laboratory, an analytical method needs to be transferred to one or several production laboratories, because measured outcomes among the laboratories must agree. To state agreement, the locations (e.g. means) must be equivalent and the production laboratory must be non-inferior to the originating one concerning scales (e.g. standard deviations). Here, parametric and non-parametric approaches based on marginal confidence intervals for the ratio of locations and the ratio of scales are presented. These intervals are appropriate for a matched pairs design without repeated measurements. Results of simulation studies investigating the power and the control of the type I error are shown and limits of the approaches are discussed. In addition, a Bland-Altman plot with tolerance intervals is proposed. As illustrated in the example proportional differences greatly improve the interpretation of the results compared to absolute differences.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Frömke C,Hothorn LA,Sczesny F,Onken J,Schneider Mdoi
10.1016/j.jpba.2012.10.032subject
Has Abstractpub_date
2013-02-23 00:00:00pages
186-93eissn
0731-7085issn
1873-264Xpii
S0731-7085(12)00572-9journal_volume
74pub_type
杂志文章abstract：:We have developed a simple and rapid time-resolved fluoroimmunoassay (TR-FIA) for simultaneous determination of alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG) and estriol (E3) using europium and samarium ion chelate. In the proposed method, we used a combination of a 96-well microtiter plate for the AFP a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00010-2
更新日期：1999-06-01 00:00:00
abstract：:Indirect biomarkers of recombinant human growth hormone (rhGH), insulin-like growth factor-I (IGF-I), insulin-like growth factor-II (IGF-II), insulin-like growth factor binding proteins (IGFBP-2 and IGFBP-3) and insulin (C-peptide) were measured together with urinary parameters of renal damage (beta(2)-microglobulin a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.06.032
更新日期：2010-12-01 00:00:00
abstract：:Natural and synthetic opioids have efficient analgesic activity but can also be addictive. Thus, the determination of opioids and their metabolites in biological specimens is of interest in clinical and forensic toxicology laboratories. The analysis of drugs in hair provides valuable information on previous chronic dr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.10.041
更新日期：2014-02-01 00:00:00
abstract：:Charge variant profiling of therapeutic proteins is required by the International Council for Harmonisation guidelines and is traditionally performed by capillary electrophoresis or ion exchange chromatography. Recently, improvements in the hyphenation of capillary electrophoresis with mass spectrometry and the introd...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113218
更新日期：2020-06-05 00:00:00
abstract：:One of the first examples of a bienzymatic organic phase enzyme electrode (OPEE) is described. It was obtained using two enzymes (phospholipase D and choline oxidase), both immobilised in kappa-Carrageenan gel and, as electrochemical transducer, an amperometric gas diffusion electrode for oxygen. The response of the b...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00212-x
更新日期：1998-12-01 00:00:00
abstract：:Tramadol is a centrally acting analgesic drug used in veterinary and human clinical practice. Its metabolism has been largely characterized in human being but is still long to be comprehended in several animal species, especially in the dog. The aim of the present study was to develop and validate a new analytical pro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.03.016
更新日期：2010-10-10 00:00:00
abstract：:Popularity of natural-based preparations supporting the sexual potency significantly increased in recent years, which also led to the increase of illegal use of phosphodiesterase type 5 inhibitor (PDE-5) in sexual performance enhancement products. In this study, a rapid U-HPLC‒HRMS/MS method has been developed to simu...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.11.007
更新日期：2019-02-05 00:00:00
abstract：:An HPLC-UV method was developed for assay of linezolid in dog, rat, mouse, and rabbit plasma. Linezolid and the internal standard were extracted on a solid phase cartridge (SPE) and separated on a reversed-phase column (C8, 4.6x150 mm, 5 microm) with 20% acetonitrile in water as mobile phase. The SPE quantitatively re...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00310-0
更新日期：1999-06-01 00:00:00
abstract：:The possibility of the rapid identification of drug related minor components by HPLC/diode-array UV spectroscopy is demonstrated by three examples. Hydroxylated impurities (degradation products) of norgestrel (6 alpha and beta, 10 beta-hydroxy derivatives) were identified on the basis of their UV spectra and retention...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01579-5
更新日期：1995-12-01 00:00:00
abstract：:The use of gradient supercritical fluid chromatography (SFC) for the impurity profiling of pharmaceutical products is not widely practiced. Historically, the limited advancement in SFC instrumentation and the lag in column development have resulted in marginal sensitivity, selectivity and reproducibility when compared...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.05.025
更新日期：2012-11-01 00:00:00
abstract：:Capillary electrophoresis with conductivity detection is a selective and quantitative method for the analysis of counter cations, such as potassium, in pharmaceutical drug substances. It is also a sensitive and specific technique for screening and measuring inorganic impurities in drug substance samples. Both counter ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00245-9
更新日期：2000-02-01 00:00:00
abstract：:Neotuberostemonine (NS) and tuberostemonine (TS), a pair of stereoisomers, are the active components contained in Stemona tuberosa, an antitussive herbal medicine in China. Two isomers have different pharmacological efficacies, which will be related with their in vivo disposition. However, the metabolic fates of NS an...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.04.018
更新日期：2017-07-15 00:00:00
abstract：:Serum metabolic profiling can identify the metabolites responsible for discrimination between doxycycline treated and untreated chronic obstructive pulmonary disease (COPD) and explain the possible effect of doxycycline in improving the disease conditions. 1H nuclear magnetic resonance (NMR)-based metabolomics was use...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jpba.2016.09.034
更新日期：2017-01-05 00:00:00
abstract：:While capillary electrophoresis has been established as a major enantioseparation technique within the last decade, the potential of capillary electrochromatography is still studied extensively. This review summarizes recent applications of electromigration techniques with regard to the enantioseparation of chiral dru...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/s0731-7085(01)00653-7
更新日期：2002-01-15 00:00:00
abstract：:A micellar electrokinetic chromatography (MEKC) method was developed for the determination of three anti-vomiting drugs (aprepitant, dexamethasone and ondansetron) in pharmaceutical formulations. The method was optimized using a central composite design (CCD). Four main factors (borate buffer concentration, pH, methan...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.07.029
更新日期：2013-12-01 00:00:00
abstract：:A high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, using hydrophilic interaction liquid chromatography (HILIC) chromatography for the analysis of fosfomycin in human plasma and urine, has been developed and validated. The plasma method uses a simple protein precipitation using a low v...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.11.042
更新日期：2015-02-01 00:00:00
abstract：:A RP-HPLC method was developed and validated for the degradation kinetic study of 2-(2-hydroxypropanamido) benzoic acid (HPABA), a promising anti-inflammatory drug, which would provide a basis for further studies on HPABA. The effects of pH, temperature, buffer concentration and ionic strength on the degradation kinet...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.04.012
更新日期：2015-08-10 00:00:00
abstract：:GC-MS is one of the recommended analytical techniques for the identification and confirmation of opiates in urine. A method for the qualitative detection and quantitation of codeine and morphine in urine samples by this technique has been developed. This method is also suitable for the detection of their main metaboli...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(90)80140-k
更新日期：1990-01-01 00:00:00
abstract：:In this study, a green production method was used to obtain magnetic carbon nanodot/graphene oxide hybrid material (Fe3O4@C-nanodot@GO) for the magnetic solid phase extraction (MSPE) of ibuprofen (IBU) in human plasma prior to HPLC-DAD determination. For the first time in the literature, Fe3O4@C-nanodot@GO hybrid mate...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.113001
更新日期：2020-02-05 00:00:00
abstract：:Pyraclostrobin is one kind of new type methoxy acrylate fungicides that has been widely used in agriculture at present, with a lot of advantages including broad spectrum, high efficiency and high selectivity. In this work, a novel low-level impurity in the pyraclostrobin at about 0.2% was separated and characterized b...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.02.027
更新日期：2017-05-10 00:00:00
abstract：:S-Adenosyl-L-methionine (SAM) and its metabolites S-adenosyl-L-homocysteine (SAH) and methyl-thioadenosine (MTA) are endogenous compounds that are heavily involved in a variety of biochemical processes, and have therefore been the target for several assays in body fluids and tissues. Reversed-phase chromatographic beh...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80029-z
更新日期：1993-04-01 00:00:00
abstract：:Statistical modelling and experimental design (SMED) are essential tools for the development and understanding of complicated products and processes. SMED allows efficient experimentation in which all or a large subset of factors are together varied over a set of experiments, in contrast to the traditional approach of...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80185-c
更新日期：1991-01-01 00:00:00
abstract：:In this work, metabolites of cyadox (CYX) produced by liver microsomes, primary hepatocytes and intestinal microflora systems of rat, chicken and swine were identified and elucidated using ultra-performance liquid chromatography/quadrupole time-of-flight tandem mass spectrometry (UPLC/Q-TOF-MS). Expected and unexpecte...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.04.004
更新日期：2012-08-01 00:00:00
abstract：:Furoin, a benzoin analogue, was examined as novel fluorogenic reagent for the selective and sensitive LC determination of various guanidines after pre-column derivatization. The derivatization reaction was carried out at 100 degrees C for 5 min to give adducts that were separated on a Phenomenex Synergi MAX-RP column ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.07.017
更新日期：2008-11-04 00:00:00
abstract：:A method is presented for the direct determination of mephenoxalone and acetaminophen in combined pharmaceutical dosage forms without prior separation. The first method, derivative-differential spectrophotometry, comprised of measurement of the difference absorptivities derivatized in the first order (deltaD1) of a ta...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00157-0
更新日期：1999-11-01 00:00:00
abstract：:In this paper the development and validation of a method for the analysis of THC-COOH, THC, THC-OH, CBD and CBN in their total form in urine by LC-MS/MS is presented. Tandem hydrolysis, i.e. enzymatic and basic, has been found optimal for the simultaneous analysis of the selected analytes in urine: basic hydrolysis is...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.12.035
更新日期：2014-03-01 00:00:00
abstract：:The extensive analytical characterization of protein biotherapeutics, especially of biosimilars, is a critical part of the product development and registration. High-resolution mass spectrometry became the primary analytical tool used for the structural characterization of biotherapeutics. Its high instrumental sensit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2018.08.024
更新日期：2018-11-30 00:00:00
abstract：:Glimepiride (Amaryl), which is a new oral antidiabetic drug in the sulfonylurea class, was analysed by using second order derivative UV spectrophotometry. The quantification of glimepiride in dimethylformamide was performed in the wavelength range of 245-290 nm at N = 6, ?lambda = 21. The second order derivative spect...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00445-3
更新日期：2001-01-01 00:00:00
abstract：:To separate proteins solely based on their difference in hydrodynamic volume in size exclusion chromatography (SEC), the ionic strength of the mobile phase has to be increased in order to avoid secondary ionic interactions between proteins and the stationary phase. However, adding salts to the mobile phase can have a ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.09.031
更新日期：2017-09-10 00:00:00
abstract：:A new HPLC method for the determination of puerarin in cerebral ischemia reperfusion rat plasma is introduced. Puerarin, the principal bioactive component of puerariae radix isoflavone, was extracted from plasma by methanol. The HPLC separation was then performed on a reversed-phase C18 column using water-acetonitrile...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.10.046
更新日期：2005-02-23 00:00:00
