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 operator's safety and using secured analytical tools like NIRS. A NIRS method was first developed and validated in compliance with current guidelines. The novelty of this work first lies in the large number of samples prepared for a wide moisture calibration range of 0.51%-4.01%. Then, the classical Partial Least Square (PLS) regression was used as chemometric tool for the computation of the model. Excellent predictive calibration results were shown. A coefficient of correlation (r) value of 0.99 was obtained. An intercept value of 0.02 and a slope of 0.99 were observed, while the root mean square error of calibration (RMSEC) and the root mean square error of prediction (RMSEP) were respectively 0.10% and 0.12%. In addition, instrumentation, model performances and robustness of the method were evaluated, demonstrating the validation results. Calibration transfer issue and impact of the number of samples were also evaluated. Consequently, a validation strategy was introduced as a basis for submission to the health authorities' for release and stability activities in a cGMP environment in replacement of the KF method.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Clavaud M,Roggo Y,Dégardin K,Sacré PY,Hubert P,Ziemons Edoi
10.1016/j.jpba.2016.09.014subject
Has Abstractpub_date
2016-11-30 00:00:00pages
380-390eissn
0731-7085issn
1873-264Xpii
S0731-7085(16)30602-1journal_volume
131pub_type
杂志文章abstract::A method of analysis of SC-560 (5-(4-chlorophenyl)-1-(4-methoxyphenyl)-3-(trifluoromethyl)-1H-pyrazole) in biological fluids is necessary to study the kinetics of in vitro and in vivo metabolism. A simple high-performance liquid chromatographic method was developed for simultaneous determination of SC-560 and other pr...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2004.03.013
更新日期:2004-09-03 00:00:00
abstract::Prostate cancer (PCa) is the most commonly diagnosed cancer in men worldwide. It is essentially dependent on potent androgens, such as testosterone (T) and dihydrotestosterone (DHT). The precursors of T and DHT, which includes androstenedione (A4) and dihydroepiandrosterone (DHEA), and also the metabolites of DHT, 5α-...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2015.07.039
更新日期:2015-11-10 00:00:00
abstract::A chiral HPLC method was developed for the quantitation of R(-)- and S(+)-prilocaine in human serum. The method involves sensitive and selective detection of R(-)- and S(+)-prilocaine using normal-phase chiral HPLC on a pirkle-type naphthyl ethylamine stationary phase (Sumichiral OA-4700, 250 mm x 4 mm i.d.) at ambien...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(96)01872-9
更新日期:1996-12-01 00:00:00
abstract::There must be a large market for active pharmaceutical ingredients of illegal source to support the huge and lucrative business of trade in illegal medicines. The active substances found in illegal pharmaceuticals may differ from their legal counterparts concerning purity and associated risks for the health of the use...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2016.08.027
更新日期:2016-11-30 00:00:00
abstract::Methods of high sensitivity, accuracy and throughput are needed for quantitation of low level residual host cell DNA in purification process intermediates and drug substances of therapeutic proteins. In this study, we designed primer/probe sets targeting repetitive Alu repeats or Alu-equivalent sequences in the human,...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2014.07.037
更新日期:2014-11-01 00:00:00
abstract::The analysis of biogenic amines (BAs) and their metabolites is helpful for the diagnosis of central nervous system disorders and other neuroendocrine and cancer disturbances. In the study, a developed micellar electrokinetic chromatography method, coupled with diode array detection (MEKC-DAD), was validated to monitor...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2019.05.021
更新日期:2019-09-05 00:00:00
abstract::Homochirality is essential for life. For a long time, it was considered that d-amino acids were excluded from living systems. In the past 30 years, however, d-amino acids have been found in living organisms in the form of free amino acids, peptides and proteins, owing to advances in the analysis of optical isomers of ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/j.jpba.2015.04.029
更新日期:2015-12-10 00:00:00
abstract::A high throughput method was developed and validated for the quantitative determination of LAG078, a lipid-lowering compound, in dog plasma obtained during toxicokinetic studies. The method was based on reverse phase liquid chromatographic separation of the analyte from plasma extract followed by turbo-ionspray (TIS) ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2004.02.020
更新日期:2004-06-29 00:00:00
abstract::A high-performance size exclusion chromatographic procedure using a Nucleosil Diol column and fluorescence detection has been developed for the determination of dextran-naproxen ester pro-drugs with varying molecular weights and degrees of substitution in aqueous buffer solutions and biological media in the presence o...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(89)80053-6
更新日期:1989-01-01 00:00:00
abstract::Two methods are described for the simultaneous determination of tizanidine and rofecoxib in binary mixture. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 311 nm. The separation was carried out on Merck HPTLC aluminium sheets of silica gel 60 F2...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2004.09.036
更新日期:2005-02-07 00:00:00
abstract::The FT-Raman quantification of atorvastatin calcium in tablets was performed using the partial least squares (PLS), principal component regression (PCR) and counter-propagation artificial neural networks (CP-ANN) methods. To compare the predictive abilities of the elaborated models, the relative standard errors of pre...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.10.015
更新日期:2009-01-15 00:00:00
abstract::Pharmaceuticals are produced according to current pharmacopoeias, which require quality parameters. Tablets of identical formulation, produced by different factories should have the same properties before and after storage. In this article, we analyzed samples having two different origins before and after storage (30 ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2004.08.009
更新日期:2004-11-19 00:00:00
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::End-stage renal disease (ESRD) is the last stage of chronic kidney disease, characterized by the progressive accumulation of uremic toxins (UTs). Hemodialysis is the standard approach to remove UTs from the body. Creatinine and urea levels are important indices of hemodialysis effectiveness, but the utility of those m...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2020.113551
更新日期:2020-11-30 00:00:00
abstract::A high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (HPLC-QTOF-MS) method in both positive and negative ion modes was established to investigate the major constituents in the ethanolic extract of Centipeda minima (EBSC). Twelve common components including flavones and thei...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2016.04.029
更新日期:2016-06-05 00:00:00
abstract::Organic solvents such as methanol, acetone, dichloromethane or toluene are frequently used in the pharmaceutical industry. The manufacturing of new active pharmaceutical ingredients (APIs) under GMP conditions commands to control adequately the quality of the different ingredients happening in the synthesis. Organic s...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2005.06.036
更新日期:2006-02-13 00:00:00
abstract::Co-crystallization brings new opportunities for improving the solubility and dissolution rate of drugs with the chance of finely tuning some relevant chemical-physical properties of mixtures containing bioactive compounds. As co-crystallization process involves several molecular species, which are generally solid at r...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.01.042
更新日期:2013-05-05 00:00:00
abstract::A slurry suspension sampling technique has been developed and optimized for rapid multielemental analysis of multivitamin/multimineral preparations using inductively coupled plasma atomic emission spectrometry (ICP-AES). The following macro-, micro- and trace-elements: Ca, Mg, Mn, Fe, Cr, Al, Ag, B, Ba, Bi, Cd, Co, Cu...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.02.010
更新日期:2008-07-15 00:00:00
abstract::A sensitive and simple high-performance liquid chromatography (HPLC) method was developed and validated for the analysis of amoxicillin in mouse serum and broncho-alveolar lavage (BAL) fluid. One hundred microlitres of sample were needed for the assay. Sample processing was carried out with liquid-liquid extraction. C...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2005.04.021
更新日期:2005-09-15 00:00:00
abstract::750 MHz 1H NMR spectroscopy has been used to characterise in detail the abnormal low molecular weight metabolites of urine from two patients with inborn errors of metabolism. One case of the rare condition 2-hydroxyglutaric aciduria has been examined. There is at present no rapid routine method to detect this genetic ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(97)00066-6
更新日期:1997-07-01 00:00:00
abstract::In this work the interaction of DNA and the flavonoid-transition metal complex (Cu(II)-naringin complex) is characterized. The interaction was evaluated by using electrochemical ssDNA- and dsDNA-based biosensors and the results were supported by UV, CD and (1)H NMR data. In the electrochemical method, changes in the o...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.08.007
更新日期:2007-12-21 00:00:00
abstract::A simple, sensitive and rapid liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quantification of gabapentin, a new antiepileptic drug, in human plasma using its structural analogue, 1,1-cyclohexane diacetic acid monoamide (CAM) as internal standard. The method involv...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2005.07.012
更新日期:2006-02-13 00:00:00
abstract::Detection of higher-order aggregates (HOA) using size-exclusion chromatography (SEC) was found to be variable for a basic protein, using exposed-silanol or diol-silica-based SEC columns. Preparations of the tetrameric biopharmaceutical enzyme Erwinia chrysanthemil-asparaginase (ErA), which has an isoelectric point of ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2017.03.004
更新日期:2017-05-30 00:00:00
abstract::A straightforward and sensitive reversed-phase high-performance liquid chromatography (HPLC) assay was developed and validated for the analysis of osthol and its phase I metabolites (internal standard: umbelliferone). The method was validated for the determination of osthol with respect to selectivity, precision, line...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.12.001
更新日期:2009-07-12 00:00:00
abstract::An analytical method for nipecotic acid quantification in rat blood was developed utilizing a stable isotope internal standard and capillary gas chromatography-mass spectroscopy. The method involves a solid phase extraction step followed by a two-step derivatization. The analytes are separated by capillary gas chromat...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2003.11.019
更新日期:2004-03-10 00:00:00
abstract::A high-performance liquid chromatographic method for the determination of lomefloxacin in human plasma has been developed and validated. A solid-phase extraction procedure was used to isolate lomefloxacin from the biological matrix prior to the quantitative analysis. The compound was separated on a Vydac anion-exchang...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(93)80089-j
更新日期:1993-11-01 00:00:00
abstract::An ion mobility spectrometry (IMS) method was developed to screen for the presence of undeclared synthetic erectile dysfunction (ED) drugs or drug analogues in herbal dietary supplements claiming to enhance male sexual performance. Ion mobility spectra of authenticated reference materials including three FDA approved ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.12.002
更新日期:2009-04-05 00:00:00
abstract::The objective of the work was to assess the possible interactions between the model drug diclofenac sodium (DS) and the water-insoluble ammonio methacrylate copolymer (AMC). Films with different drug/polymer ratios were therefore prepared by the solvent casting method and investigated as a preformulation study towards...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.10.008
更新日期:2008-01-22 00:00:00
abstract::Sulodexide is a heparinoid which combines the properties of its components heparin and dermatan sulfate and is used not only for the prophylaxis and treatment of thromboembolic diseases but also for the treatment of diabetic nephropathy. Despite many clinical studies have been conducted to investigate its activity and...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2018.04.012
更新日期:2018-07-15 00:00:00
abstract::The contamination of commonly used supplements by unknown steroids as well as their metabolites (parent compounds) become a challenge for the analytical laboratories. Although the determination of steroids profile is not trivial because of the complex matrix and low concentration of single compound, one of the most di...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2014.11.017
更新日期:2015-03-15 00:00:00