Abstract：
:Assessment of analytical variability is recognized as an important factor for the establishment of specifications. Estimation of the variance for an analytical procedure can be accomplished using a variety of approaches. The approach of variance component analysis was applied retrospectively, as well as prospectively, to estimate analytical variance. The prospective approach also included the use of experimental design. Recent new drug substance examples illustrating these approaches are presented. In these examples, the analytical property of potency was evaluated. Factors examined in the experimental design include laboratory, day, analyst, instrument and column. Process variability can also be determined by variance component analysis. For a stable drug substance, combining the analytical and process variances provides an estimate on the total variance for the analytical property of potency. With the total variability statistically derived, an appropriate specification that is consistent with process and analytical capability can be established.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Tsang PK,Larew JS,Larew LA,Miyakawa TW,Hofer JDdoi
10.1016/s0731-7085(97)00266-5subject
Has Abstractpub_date
1998-03-01 00:00:00pages
1125-41issue
7eissn
0731-7085issn
1873-264Xpii
S0731-7085(97)00266-5journal_volume
16pub_type
杂志文章abstract：:Novel approaches to the development of analytical procedures for monitoring incoming starting material in support of chemical/pharmaceutical processes are described. High technology solutions were utilized for timely process development and preparation of high quality clinical supplies. A single robust HPLC method was...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00333-2
更新日期：2000-08-15 00:00:00
abstract：:The nonreceptor tyrosine kinase FynB is known to be required in the induction of long-term potentiation (LTP), a cellular mechanism for learning and memory. Ligands of the FynB SH2 domain as a possible FynB activator are, thus, of great interest. In this study, a solid-phase ligand binding assay was established to mee...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00507-6
更新日期：2002-01-01 00:00:00
abstract：:Ethylphenidate is a new potent synthetic psychoactive drug, structurally related to methylphenidate. Using human liver microsomes and cytosol, we have investigated for the first time the Phase-I and Phase-II in vitro metabolism of ethylphenidate. The structure of the metabolites was elucidated by hybrid quadrupole tim...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.09.029
更新日期：2016-01-05 00:00:00
abstract：:A dedicated proteomic approach based on nano-Liquid Chromatography coupled with tandem mass spectrometry in ion trap is proposed for the analysis of proteins trapped in sorbent resin cartridges used to remove inflammatory mediators from blood by coupled plasma filtration adsorption (CPFA). The final purpose of the pro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.10.009
更新日期：2017-01-05 00:00:00
abstract：:In traditional Chinese medicine practice, crude herbs are often subjected to traditional processing (Paozhi in Chinese) for a special medicinal purpose. Bran-frying is one of processing methods for Paeoniae Radix Alba (PRA). Previous studies found that paeoniflorin and paeoniflorin sulfonate, a principle bioactive com...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.07.003
更新日期：2018-09-10 00:00:00
abstract：:4-Methoxydiphenylmethane (4-MDM), a selective augmenter of Leukotriene A4 Hydrolase (LTA4H), is a new anti-inflammatory compound for potential treatment of chronic obstructive pulmonary disease (COPD). Currently, there is no liquid chromatography tandem mass spectrometric (LC-MS/MS) method for the quantification of 4-...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.05.014
更新日期：2016-09-05 00:00:00
abstract：:A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DM chiral stationary phase (CSP) towards sertraline and its related enantiomers. The effect of pH, buffer concentration as well as nature of organic mo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.04.038
更新日期：2009-10-15 00:00:00
abstract：:This paper puts forward a method to describe an equation of the within-plate uncertainty (relative standard deviation (R.S.D.) of measurements) as a function of analyte concentration in sandwich enzyme-linked immunosorbent assay (ELISA). A kit for thyroid stimulating hormone is taken as an example. The pipetting proce...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.05.017
更新日期：2004-09-21 00:00:00
abstract：:Kumariasava is a marketed ayurvedic formulation containing Aloe vera as one of the main ingredients. Present study aims to standardize Kumariasava based upon chromatographic and spectral studies. Various extracts of Kumariasava have been prepared and evaluated. Chloroform extract indicated presence of three well-resol...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.11.044
更新日期：2005-04-29 00:00:00
abstract：:A new method for the determination of 2-[(dimethylamino)methyl]cyclohexanone (DAMC) in Tramadol (as active substance or active ingredient in pharmaceutical formulations) is described. The method is based on the derivatisation of 2-[(dimethylamino)methyl]cyclohexanone with 2,4-dinitrophenylhydrazine (2,4-DNPH) in acidi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.japna.2003.07.003
更新日期：2004-01-27 00:00:00
abstract：:Linezolid (LZD) is a widely used antimicrobial that is active against a broad range of disease-causing bacteria. Myelosuppression is major treatment-limiting toxicity of LZD that occurs more frequently in patients with renal insufficiency. Quantification of LZD and its two primary metabolites (PNU-142300 and PNU-14258...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112968
更新日期：2020-01-30 00:00:00
abstract：:A reversed-phase HPLC method is described for the simultaneous determination of nifedipine and its primary pyridine metabolite dehydronifedipine in blood and plasma, that involves UV detection and neutral (blood) or alkaline (plasma) extraction. The limit of reliable determination is found to be 3 ng ml-1 with an inte...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/0731-7085(91)80249-9
更新日期：1991-01-01 00:00:00
abstract：:The IgG activities of antigen recognition, Fc-mediated complement activation and cellular Fcγ-receptors (FcγRs) binding are critical for intravenous immunoglobulin (IVIg) immunotherapy in a variety of immune deficiency diseases. Further, these activities could be influenced by different plasma sources and the IVIg man...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.01.021
更新日期：2018-03-20 00:00:00
abstract：:A method using reverse phase liquid chromatography-tandem mass spectrometry and cassette administration was developed for in vivo brain and plasma exposure profiling to assist early CNS drug discovery programs. Three to four compounds were grouped in cassettes for dosing and analysis. Compounds in the cassettes were s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/S0731-7085(03)00523-5
更新日期：2004-02-04 00:00:00
abstract：:QuEChERS sample preparation was optimized using solvent extraction with acetonitrile and dispersive-solid phase extraction with primary and secondary amine sorbents, and validated for high-performance liquid chromatographic determination of nine steroids commonly used to adulterate herbal medicines: such as triamcinol...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.03.046
更新日期：2011-07-15 00:00:00
abstract：:The objective of this paper is to evaluate the variations in the ability of Pistacia atlantica leaves to inhibit enzymes linked to type 2 diabetes (α-amylase and α-glucosidase) and to hypertension (angiotensin converting enzyme-I (ACE-I)), depending on harvesting month, gender and growing region, as well as to identif...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.11.049
更新日期：2018-02-05 00:00:00
abstract：:The principles of multivariate calibration (MC) are presented, with reference to the main objectives of this chellometrics technique: the reduction of the variance in the prediction of a response variable (generally, a chemical quantity) and the possibility of the determination of the response in complex matrices with...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/s0731-7085(98)00153-8
更新日期：1998-10-01 00:00:00
abstract：:A rapid and sensitive ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was applied to investigate the permeability characteristics and transport mechanism of trihexyphenidyl hydrochloride (TH) in D-hanks with the Caco-2 cells model. Analytes were separated using an Zorbax Exten...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112924
更新日期：2020-01-30 00:00:00
abstract：:A rapid analytical procedure for routine identification and quantification of amoxicillin in premixes by high performance liquid chromatography was developed and tested. The ground premix samples were extracted for 10 min using 100ml extraction mixture water-methanol (800:200, v/v). The extract was analyzed by reverse...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.10.010
更新日期：2005-02-23 00:00:00
abstract：:This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were d...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2013.07.013
更新日期：2013-12-01 00:00:00
abstract：:Remifentanil is an ultra-short-acting opioid under evaluation for use during surgical procedures which require opioid analgesia or anesthesia. It has an N-substituted methyl propanoate ester group which is highly susceptible to clevage by blood and tissue esterases as well as to chemical hydrolysis. A selective and sp...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(96)01831-6
更新日期：1996-09-01 00:00:00
abstract：:The five active drug substances and two of the excipients present in Frenadol, a cold medication, were separated. The active drug components dextromethorphan HBr monohydrate, ascorbic acid, caffeine, paracetamol and chlorpheniramine maleate were quantitatively assayed by a mixed ion pair LC method. The excipients sepa...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(94)80014-6
更新日期：1994-01-01 00:00:00
abstract：:The purpose of this work was to demonstrate the possibilities offered by laser-induced breakdown spectroscopy (LIBS) for the direct and rapid analysis of pharmaceutical liquid formulations. Sodium chloride in solution was chosen as a model compound. A pulsed Nd:YAG laser (1064 nm) was used to produce a gaseous plasma ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.06.004
更新日期：2004-10-29 00:00:00
abstract：:The level of free polysaccharide is a critical quality attribute of polysaccharide-protein conjugate vaccines. The work presented describes a simple and sensitive method for the determination of low level free polysaccharides in multiple polysaccharide-protein conjugates. The method utilizes a reverse phase (RP) colum...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.113043
更新日期：2020-02-20 00:00:00
abstract：:The use of Near-infrared spectroscopy (NIRS) as a fast and non-destructive technique was employed for moisture content (MC) determination in Antibody-drug conjugates (ADCs) in replacement to Karl Fischer (KF) method. The lab analysis of ADCs, high potent medicines, should be performed in conditions ensuring the operat...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.09.014
更新日期：2016-11-30 00:00:00
abstract：:Both a GC-MS and an LC method have been developed for the simultaneous quantitation of dolasetron and reduced dolasetron in human plasma. The GC-MS method has been utilized in preliminary human pharmacokinetic studies of dolasetron mesylate. Selected ion monitoring was used in these initial studies to obtain the sensi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80055-6
更新日期：1993-10-01 00:00:00
abstract：:Radix Dipsaci (RD), the dried root of Dipsacus asper, is commonly used as a traditional Chinese medicine for the treatment of bone diseases and functions in strengthening bone and healing bone fractures. Nevertheless, the high polarity, non chromophores and low abundance of multiple compounds in this plant bring diffi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.05.006
更新日期：2014-09-01 00:00:00
abstract：:In this study, a new approach using 1H NMR spectroscopy combined with chemometrics method was developed for qualitative and quantitative analyses of extracts of Compound Danshen Dripping Pills (CDDP). For the qualitative analysis, some metabolites presented in Compound Danshen extract (CDE, extraction intermediate of ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.08.017
更新日期：2016-11-30 00:00:00
abstract：:Chronic kidney disease (CKD) is a progressive pathological condition in which renal function deteriorates in time. The first diagnosis of CKD is often carried out in general care attention by general practitioners by means of serum creatinine (CNN) levels. However, it lacks sensitivity and thus, there is a need for ne...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.10.036
更新日期：2018-02-05 00:00:00
abstract：:The supposed 5-LO inhibitory activity of two N-omega-ethoxycarbonyl-4-quinolones was tested determining leukotriene B4 (LTB4) in RBL-1 cell cultures, pretreated with the two compounds of interest. LTB4, obtained by solid-phase extraction (SPE) from cell cultures supernatants, was determined by micellar electrokinetic ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00250-7
更新日期：1999-03-01 00:00:00
