Literature DB >> 16076542

Guidelines from the International Conference on Harmonisation (ICH).

Sarah K Branch1.   

Abstract

This article describes the development of international guidance on registration of technical dossiers supporting applications to market medicinal products. Aspects of guidance of particular relevance to the use of NMR spectroscopy in drug development and control are discussed.

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Year:  2005        PMID： 16076542     DOI： 10.1016/j.jpba.2005.02.037

Source DB:  PubMed          Journal:  J Pharm Biomed Anal        ISSN： 0731-7085            Impact factor:   3.935


  22 in total

1.  Synthetic ECG generation and Bayesian filtering using a Gaussian wave-based dynamical model.

Authors:  Omid Sayadi; Mohammad B Shamsollahi; Gari D Clifford
Journal:  Physiol Meas       Date:  2010-08-18       Impact factor: 2.833

2.  Stability of benzocaine formulated in commercial oral disintegrating tablet platforms.

Authors:  Melanie Köllmer; Carmen Popescu; Prashanth Manda; Leon Zhou; Richard A Gemeinhart
Journal:  AAPS PharmSciTech       Date:  2013-08-30       Impact factor: 3.246

3.  Application of a proton quantitative nuclear magnetic resonance spectroscopy method for the determination of actinodaphnine in Illigera aromatica and Illigera henryi.

Authors:  Jian-Wei Dong; Xue-Jiao Li; Jun-You Shi; Kai-Quan Liu
Journal:  J Nat Med       Date:  2018-11-09       Impact factor: 2.343

4.  Rapid and sensitive online determination of some selective α1-blockers by flow injection analysis with micelle-enhanced fluorescence detection.

Authors:  Niveen A Mohamed; Sameh Ahmed; Sally A El Zohny
Journal:  J Fluoresc       Date:  2013-07-20       Impact factor: 2.217

5.  Robot-assisted thoracoscopic surgery versus thoracotomy for c-N2 stage NSCLC: short-term outcomes of a randomized trial.

Authors:  Jia Huang; Chongwu Li; Hecheng Li; Fanzhen Lv; Long Jiang; Hao Lin; Peiji Lu; Qingquan Luo; Wenrong Xu
Journal:  Transl Lung Cancer Res       Date:  2019-12

6.  Quality by Design (QbD)-Based Numerical and Graphical Optimization Technique for the Development of Osmotic Pump Controlled-Release Metoclopramide HCl Tablets.

Authors:  Sadaf Farooqi; Rabia Ismail Yousuf; Muhammad Harris Shoaib; Kamran Ahmed; Sabah Ansar; Tazeen Husain
Journal:  Drug Des Devel Ther       Date:  2020-11-26       Impact factor: 4.162

7.  Effects of highly hygroscopic excipients on the hydrolysis of simvastatin in tablet at high relative humidity.

Authors:  W L Chen; D W Guo; Y Y Shen; S R Guo; K P Ruan
Journal:  Indian J Pharm Sci       Date:  2012-11       Impact factor: 0.975

8.  Fruit and soil quality of organic and conventional strawberry agroecosystems.

Authors:  John P Reganold; Preston K Andrews; Jennifer R Reeve; Lynne Carpenter-Boggs; Christopher W Schadt; J Richard Alldredge; Carolyn F Ross; Neal M Davies; Jizhong Zhou
Journal:  PLoS One       Date:  2010-09-01       Impact factor: 3.240

9.  Development of a High-Performance Thin-Layer Chromatography Method for the Quantification of Alkyl Glycerolipids and Alkenyl Glycerolipids from Shark and Chimera Oils and Tissues.

Authors:  Marion Papin; Cyrille Guimaraes; Benoit Pierre-Aue; Delphine Fontaine; Jeoffrey Pardessus; Hélène Couthon; Gaëlle Fromont; Karine Mahéo; Aurélie Chantôme; Christophe Vandier; Michelle Pinault
Journal:  Mar Drugs       Date:  2022-04-18       Impact factor: 6.085

10.  Method Validation Approaches for Analysis of Constituents in ENDS.

Authors:  Samantha M Reilly; Tianrong Cheng; Jenna DuMond
Journal:  Tob Regul Sci       Date:  2020-07
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