搜索页_Analytical+results+harmonisation

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在“Elsevier电子期刊”中，命中：57条，耗时：0.0179911 秒

在所有数据库中总计命中：122条

1.Development of nanostructured lipid carriers containing salicyclic acid for dermal use based on the Quality by Design method

作者：A. Ková ; cs ; ^{anita.kovacs@pharm.u-szeged.hu} ; Sz. Berkó ; ^{berko@pharm.u-szeged.hu} ; E. Csá ; nyi ^{csanyi@pharm.u-szeged.hu} ; I. Csó ; ka ^{csoka@pharm.u-szeged.hu}

关键词：API ; active pharmaceutical ingredient ; CMAs ; critical material attributes ; CCS ; critical control strategy ; CPPs ; critical process parameters ; CQAs ; critical quality attributes ; DoE ; design of experiments ; DS ; design space ; ICH ; International Council for Harmonisation ; LD ; laser diffraction ; MP-SA ; micro-sized lipid particle containing salicyclic acid ; NLC SA ; nanostructured lipid carriers containing salicyclic acid ; NSAID ; non-steroidal anti-inflammatory drug ; PAT ; process analytical technology

刊名：European Journal of Pharmaceutical Sciences

出版年：2017

2.Assessing analytical comparability of biosimilars: GCSF as a case study

作者：Neh Nupur ; Sumit Kumar Singh ; Gunjan Narula ; Anurag S. Rathore ; ¹ ; ^{asrathore@biotechcmz.com" class="auth_mail" title="E-mail the corresponding author}

关键词：CQA ; critical quality attributes ; GCSF ; granulocyte colony stimulating factor ; CD ; circular dichroism spectroscopy ; RPC ; reverse phase chromatography ; SEC ; size exclusion chromatography ; FLD ; fluorescence detector ; mAbs ; monoclonal antibodies ; PTM ; post translational modification ; ICH ; International Conference on Harmonisation ; CID ; collision induced dissociation ; ETD ; electron transfer dissociation ; HSQC NMR ; heteronuclear single quantum coherence nuclear magnetic resonance spectroscopy ; CDSCO

刊名：Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences

出版年：2016

3.Study of common database feeding with results coming from different analytical methods in the framework of illicit drugs chemical profiling

作者：Julian Bros¨¦us ; Benjamin Debrus ; Olivier Del¨¦mont ; Serge Rudaz ; Pierre Esseiva

关键词：Analytical results harmonisation ; Analytical methods harmonisation ; GC&ndash ; MS ; Fast GC-FID ; Chemical profiles similarity ; Mathematical adjustment

刊名：Forensic Science International

出版年：2013

4.Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets

作者：Margot Fonteyne^a ; ^{Margot.Fonteyne@Ugent.be" class="auth_mail} ; Henrika Wickströ ; m^a ; ^b ; Elisabeth Peeters^c ; Jurgen Vercruysse^c ; Henrik Ehlers^b ; Bjö ; rn-Hendrik Peters^d ; Jean Paul Remon^c ; Chris Vervaet^c ; Jarkko Ketolainen^d ; Niklas Sandler^b ; Jukka Rantanen^e ; Kaisa Naelapä ; ä ; ^e ; ¹ ; Thomas De Beer^a ; ^{Thomas.Debeer@Ugent.be" class="auth_mail}

关键词：ICH ; International Conference on Harmonisation ; PAT ; Process Analytical Technology ; API ; Active Pharmaceutical Ingredient ; BET ; Brunauer&ndash ; Emmett&ndash ; Teller ; CQA ; critical quality attributes ; FDA ; food and drug administration ; HPMC ; hydroxypropylmethylcellulose ; MCC ; microcrystalline cellulose ; PC ; Principal Component ; PCA ; Principal Component Analysis ; PLS ; partial least squares ; PVP ; polyvinylpyrrolidone ; QbD ; Quality by Design ; rpm ; rotations per minute ; SNV ; standard normal variate ; UV

刊名：European Journal of Pharmaceutics and Biopharmaceutics

出版年：July 2014

5.The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: Study design, data analysis, interpretation

作者：Hervé ; Lebrec^a ; ^{hlebrec@amgen.com" class="auth_mail} ; Brigitte Molinier^b ; Darrell Boverhof^c ; Mark Collinge^d ; Wendy Freebern^e ; Kristin Henson^f ; Daniel T. Mytych^g ; Hans D. Ochs^h ; Ronald Wangeⁱ ; Yung Yang^j ; Lei Zhou^g ; Joshua Arrington^k ; Marie Soleil Christin-Piché ; ^l ; Jacintha Shenton^m

关键词：APC ; antigen presenting cells ; AUC ; area under the curve ; CP ; cut point ; ECL ; electrochemiluminescence ; ELISA ; enzyme-linked immunosorbent assay ; EPA ; Environmental Protection Agency ; GLP ; good laboratory practice ; HMW ; high molecular weight ; HBsAg ; Hepatitis B surface antigen ; ICH ; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ; Ig ; immunoglobulin ; KLH ; keyhole limpet hemocyanin ; NHP ; non-human primates ; NSB ; non-specific bi

刊名：Regulatory Toxicology and Pharmacology

出版年：June, 2014

6.Advancing toxicology in RiskMAPP: Setting ADEs based on the subsequent drug substance

作者：Joel P. Bercu ; ^{jbercu@amgen.com} ; Rizwan Sharnez ; David G. Dolan

关键词：ADE ; acceptable daily exposure ; BW ; body weight ; DSA ; first drug substance used in processing drug equipment ; DSB ; subsequent drug substance used in processing drug equipment ; EMA ; European Medicines Agency ; ICH ; International Conference on Harmonisation

刊名：Regulatory Toxicology and Pharmacology

出版年：2013

7.Codex dietary fibre definition - Justification for inclusion of carbohydrates from 3 to 9 degrees of polymerisation

作者：Elizabete Wenzel de Menezes ; ^{wenzelde@usp.br} ; Eliana Bistriche Giuntini ; Milana Cara Tanasov Dan ; Fabiana André ; a Hoffmann Sardá ; Franco Maria Lajolo

关键词：Dietary ; Definition ; Codex Alimentarius ; Carbohydrates ; Degree of polymerisation

刊名：Food Chemistry

出版年：2013

8.Rapid, simple and stability-indicating determination of polyhexamethylene biguanide in liquid and gel-like dosage forms by liquid chromatography with diode-array detection

作者：Markus K眉sters ; S枚ren Beyer ; Stephan Kutscher ; Harald Schlesinger ; Michael Gerhartz

关键词：Polyhexamethylene biguanide ; Polyhexanide ; Pharmaceuticals ; High performance liquid chromatography

刊名：Journal of Pharmaceutical Analysis

出版年：December, 2013

9.Exposure to brominated flame retardants, perfluorinated compounds, phthalates and phenols in European birth cohorts: ENRIECO evaluation, first human biomonitoring results, and recommendations

作者：Maribel Casas^a ; ^b ; ^c ; ^{mcasas@creal.cat} ; Cé ; cile Chevrier^d ; Elly Den Hond^e ; Mariana F. Fernandez^c ; ^f ; Frank Pierik^h ; ⁱ ; Claire Philippat^g ; Ré ; my Slama^g ; Gunnar Toft^j ; Sté ; phanie Vandentorren^k ; Michael Wilhelm^l ; Martine Vrijheid^a ; ^b ; ^c

关键词：BFRs ; brominated flame retardants ; BPA ; bisphenol A ; COPHES ; Consortium to Perform Biomonitoring on a European Scale ; ENRIECO ; ENvironmental Health RIsks in European Birth Cohorts ; HBCD ; hexabromocyclododecane ; JEM ; job exposure matrix ; PBBs ; polybrominat

刊名：International Journal of Hygiene and Environmental Health

出版年：2013

10.Review of analytical methods to measure boar taint compounds in porcine adipose tissue: The need for harmonised methods

作者：J.-E. ; Haugen^a ; ; ^{john-erik.haugen@nofima.no} ; C. ; Brunius^b ; G. ; Zamaratskaia^b

关键词：Androstenone ; Skatole ; Chromatography ; Immunoassay ; Spectrophotometry

刊名：Meat Science

出版年：2012

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