Abstract：
:The method validation strategy described consists of four components which are the prevalidation, validation proper, study proper and statistical analyses. These components constitute the platform upon which to evaluate the reliability and reproducibility of a bioanalytical method. Consideration has been given to emulate the study proper conditions to understand the method's limitations and performance expectations. The validation strategy will be presented in two papers. This first paper will describe the overall validation strategy, and the second paper will discuss the statistical analyses and data interpretation.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Lang JR,Bolton Sdoi
10.1016/0731-7085(91)80159-7subject
Has Abstractpub_date
1991-01-01 00:00:00pages
357-61issue
5eissn
0731-7085issn
1873-264Xpii
0731-7085(91)80159-7journal_volume
9pub_type
杂志文章abstract：:Drugs of long-term use may cause the accumulation of chemical compounds in human body. Therefore, the evaluation and structure characterization of synthesis and degradation impurities is substantial to guarantee drug safety and successful pharmaceutical therapy. The present work evaluated the anticoagulant rivaroxaban...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.01.053
更新日期：2016-05-10 00:00:00
abstract：:Human milk oligosaccharides (HMOs) are complex carbohydrates that exist naturally in mother's milk. Due to their myriad beneficial biological effects, HMOs are in the focus of current researches. Some of these complex carbohydrates are already commercially available utilizing their health-promoting benefits not just i...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113184
更新日期：2020-05-30 00:00:00
abstract：:A rapid, sensitive and reproducible method using ultra-high-performance liquid chromatography coupled with electrospray ionization hybrid triple quadrupole-linear ion trap mass spectrometry (UHPLC-ESI-QqQLIT-MS/MS) in multiple reaction monitoring (MRM) mode was developed and validated for simultaneous quantitation of ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.12.040
更新日期：2018-03-20 00:00:00
abstract：:Polygonum jucundum is a traditional Chinese medicine used for the treatment of diseases. The major bioactive compound in the ethanol extract of P. jucundum is 2α-hydroxyl-3β-angeloylcinnamolide (HAC), a drimane-type sesquiterpenoid, which possesses anti-inflammatory activities. The purpose of this study was to investi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.04.033
更新日期：2013-09-01 00:00:00
abstract：:Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to v...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.08.042
更新日期：2018-11-30 00:00:00
abstract：:A micellar electrokinetic chromatographic (MEKC) method was developed for the quantification of lovastatin and simvastatin, cholesterol lowering agents in pharmaceutical dosage forms. Lovastatin and simvastatin were separated using an electrolyte system consisting of 12% acetonitrile (v/v) in 25 mM sodium borate buffe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00128-0
更新日期：2002-07-20 00:00:00
abstract：:There are few methods available for the rapid and precise quantitation of non-covalent aggregation. The very methods used to measure the aggregation can easily disrupt the weak forces holding an aggregate together. This paper describes the novel application of free solution capillary electrophoresis (CE) for the quant...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00302-1
更新日期：1999-04-01 00:00:00
abstract：:In the framework of a preliminary investigation on the plasma profile of cloxacillin after oral administration, a simple and rapid LC method was developed for the direct determination of this compound in human plasma. The on-line sample clean-up was carried out using a weak anion exchanger (diethylaminoethyl groups) a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.09.017
更新日期：2005-01-04 00:00:00
abstract：:Micellar electrokinetic chromatography (nMEKC) method was applied to the determination of the partition behaviour between water and micelle for a group of antibiotics using sodium dodecyl sulphate (SDS) as an anionic model surfactant. In the method, the running buffer contains both the micelles and the drug, and the i...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00471-x
更新日期：2001-12-01 00:00:00
abstract：:Simple spectrophotometric and spectrofluorimetric methods are suggested for the determination of antifungal drugs; clotrimazole, econazole nitrate, ketoconazole, miconazole and tolnaftate. Spectrophotometric one depends on the interaction between imidazole antifungal drugs as n-electron donor with the pi acceptor 2,3-...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00280-0
更新日期：2000-03-01 00:00:00
abstract：:Chinese medicine formula (CMF) usually contains multiple herbs and its components are very complicated, which therapeutic effects are derived from the integrative activity of multiple components. Therefore, the screening of bioactive compounds in the formula is necessary, though it is very difficult, not only for eluc...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113331
更新日期：2020-07-15 00:00:00
abstract：:A new method has been devised for the determination of diclofenac sodium in bulk and in pharmaceutical preparations using Eu3+ ions as the Fluorescent probe. The technique was built around the hypersensitive property of the transitions of the fluorescent probe ion, Eu3+, at 616 nm. This is normally a forbidden transit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01567-5
更新日期：1995-10-01 00:00:00
abstract：:Hernandezine, a novel anticancer AMPK activator, is a major active constituent of Thalictrum Ranunculaceae. A simple, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantification of hernandezine in rat plasma and tissues after intraveno...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.03.038
更新日期：2017-07-15 00:00:00
abstract：:Comparison is made between conventional liquid-liquid extraction and solid-phase extraction techniques using Extrelut-1, Extrelut-3 and C18-RP cartridges respectively for the screening of several beta-blockers in urine. Generally, using GC with nitrogen specific detection as the screening technique, liquid-liquid extr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80098-0
更新日期：1988-01-01 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：: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：:The pharmaceutical industry is under stringent regulations on quality control of their products because is critical for both, productive process and consumer safety. According to the framework of "process analytical technology" (PAT), a complete understanding of the process and a stepwise monitoring of manufacturing a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.05.002
更新日期：2015-10-10 00:00:00
abstract：:Butanol and dilute sulfuric acid were used to extract paromomycin and gentamicin from Aquaphilic-based formulated creams. The extraction procedure was validated over different antibiotic concentration ranges for linearity, precision, accuracy, limited specificity, sensitivity and solution stability. ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)02044-4
更新日期：1997-09-01 00:00:00
abstract：:Di(2-ethylhexyl)phthalate (DEHP), a plasticiser present in infusion equipment, is known to be harmful to human health. Various studies have shown that DEHP is released into drug solutions from polyvinyl chloride (PVC) infusion lines. New multi-layer tubing has therefore been marketed to overcome this problem. We asses...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2003.12.018
更新日期：2004-04-01 00:00:00
abstract：:A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with multiple reaction monitoring (MRM) was developed for the determination of solanesol in Nicotiana tabacum. Sample preparation was performed by ultrasonic extraction with methanol for 20 min and then supernatant was extracted wit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.01.021
更新日期：2007-05-09 00:00:00
abstract：:Molecularly imprinted polymers (MIPs) for caffeic acid (CA) were prepared using 4-vinylpyridine and methacrylamide (MAM) as functional monomers, divinylbenzene as a crosslinker and acetonitrile-toluene (3:1, v/v) as a porogen by precipitation polymerization. The use of MAM as the co-monomer resulted in the formation o...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.12.052
更新日期：2016-08-05 00:00:00
abstract：:The binary phase diagram of (S)-(+)-4,4'-(1-methyl-1,2-ethandiyl)-bis-(2,6-piperazinedione), 1 (dexrazoxane), a cardioprotective agent, and of its (R)-(-)-enantiomer, 2, has been investigated by differential scanning calorimetry (DSC); the equimolecular mixture of 1 and 2 corresponds to a racemic compound (racemate) w...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(92)80007-a
更新日期：1992-01-01 00:00:00
abstract：:Cationic lipid-mediated drug delivery of small pharmaceutical molecules and biological molecules, such as proteins and DNA, has gained increasing popularity for many in vitro and in vivo applications. For this purpose, 1,2-dioleoyl-3-trimethylammonium propane (DOTAP) is one of the most widely used and efficient cation...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.10.001
更新日期：2010-03-11 00:00:00
abstract：:Extracts from the Carica papaya L. plant are widely reported to contain metabolites with antibacterial, antioxidant and anticancer activity. This study aims to analyze the metabolic profiles of papaya leaves and seeds in order to gain insights into their phytomedicinal constituents. We performed metabolite fingerprint...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.06.035
更新日期：2015-11-10 00:00:00
abstract：:Skin permeability of organic compounds depends on their lipophilicity but can also be affected by compounds interactions with specific skin components. A good chromatographic model of percutaneous penetration determined solely by lipophilicity is provided by the immobilized artificial membrane (IAM) columns. To comple...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)02009-2
更新日期：1997-06-01 00:00:00
abstract：:Cyanocobalamin is photolysed in aqueous solution to produce hydroxocobalamin. The kinetics of photolysis has been studied at pH 1-12 using a newly developed spectrophotometric method for the simultaneous determination of the two compounds at 550 and 525 nm or 361 and 351 nm. Cyanocobalamin follows zero-order kinetics ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(92)80004-7
更新日期：1992-01-01 00:00:00
abstract：:Greening analytical methods has become of great interest in the field of pharmaceutical analysis to protect both the operators' health and the environment. In this work, an innovative methodology combining Quality-by-Design (QbD) and Green Chemistry principles was followed to develop a single, green and robust RP-HPLC...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113507
更新日期：2020-10-25 00:00:00
abstract：:An emerging body of evidence has highlighted the significant role of the pulmonary microbiota during respiratory infections. The individual microbiome is nowadays recognized to supervise the outcome of the host-pathogen interaction by orchestrating mechanisms of immune regulation, inflammation, metabolism, and other p...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2020.113473
更新日期：2020-09-10 00:00:00
abstract：:Residual solvents (RS) are volatile organic chemicals that are used or produced during the manufacturing process of drug substances or excipients. The European Pharmacopoeia (Ph. Eur.) limits the amount of RS in pharmaceuticals, considering the International Conference on Harmonization (ICH) of Technical Requirements ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.05.015
更新日期：2008-09-10 00:00:00
abstract：:The present study deals with the stress degradation studies on amorphous and polymorphic forms of clopidogrel bisulphate. The objective was to characterize the degradation products and postulate mechanism of decomposition of the drug under solid state stress conditions. For that, amorphous form, polymorph I and polymo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.05.001
更新日期：2010-07-08 00:00:00
