Search Result "International Conference on Harmonization (ICH)"


Research Article

Establishment and Validation of an ICP-MS Method for Simultaneous Measurement of 24 Elemental Impurities in Ubenimex APIs According to USP/ICH guidelines

Journal: Current Pharmaceutical Analysis
Volume: 17 Issue: 6 Year: 2021 Page: 723-730
Author(s): Ming-Juan Zhao,Lei Cheng,Yu-Jia Huang,Ying Tao,Xiao Gu,Jin-Qi Zheng

Drug Approval Process – In United States of America, European Union and India: A Review

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 1 Issue: 1 Year: 2014 Page: 13-22
Author(s): Anjan K. Mahapatra,N.H. Sameeraja,P.N. Murthy

Research Article

ICH/FDA Guidelines-Compliant Validated Stability-Indicating HPLC-UV Method for Determination of Axitinib in Bulk and Dosage Forms

Journal: Current Analytical Chemistry
Volume: 16 Issue: 8 Year: 2020 Page: 1106-1112
Author(s): Ibrahim A. Darwish,Nasr Y. Khalil,Mohammad AlZeer

Review Article

Risk Assessment, Screening and Control of Elemental Impurities in Pharmaceutical Drug Products: a Review

Journal: Current Pharmaceutical Analysis
Volume: 16 Issue: 7 Year: 2020 Page: 801-805
Author(s): Rajesh Kumar Chawla,Subhranshu Panda,Kulandaivelu Umasankar,Siva Prasad Panda,Dalu Damayanthi

Unifying Drug Safety and Clinical Databases

Journal: Current Drug Safety
Volume: 8 Issue: 1 Year: 2013 Page: 56-62
Author(s): Barry Burnstead, Giovanni Furlan

Effects of Arginine on Photostability and Thermal Stability of IgG1 Monoclonal Antibodies

Journal: Current Pharmaceutical Biotechnology
Volume: 10 Issue: 8 Year: 2009 Page: 761-766
Author(s): Haripada Maity, Courtney ODell, Arvind Srivastava, Joel Goldstein

A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines

Journal: Current Pharmaceutical Analysis
Volume: 7 Issue: 3 Year: 2011 Page: 182-188
Author(s): Kapendra Sahu, Chandrabose Karthikeyan, Narayana S. H. N. Moorthy, Piyush Trivedi

Optimization and Formulation of Cinnarizine-Loaded Chitosan Microspheres in Liquid Dosage Form for Pediatric Therapy

Journal: Drug Delivery Letters
Volume: 4 Issue: 2 Year: 2014 Page: 128-141
Author(s): Reham Aman,Mahasen Meshali,Galal Abdelghani

Research Article

A New Stability-indicating Chiral RP-HPLC Method for the Determination of Degradation Products in Meclizine Hydrochloride

Journal: Current Pharmaceutical Analysis
Volume: 17 Issue: 8 Year: 2021 Page: 1075-1087
Author(s): Bryan Gowramma,Ramachandran Senthil Kumar,Kaviarasan Lakshmanan,Rajagopal Kalirajan,Subramania Nainar Meyyanathan

Quantitative Determination of a Novel Pseudoalkaloid Colchatetralene Isolated from the Mycoflora of Gloriosa superba Linn by HPTLC

Journal: The Natural Products Journal
Volume: 3 Issue: 3 Year: 2013 Page: 176-181
Author(s): Abhishek Budhiraja,Kunal Nepali,Vinod gouttam,Sameer Sapra,Kanaya Lal Dhar

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