Search Result "ICH Guidance"


Regulatory Review of Abbreviated Biologics Regulations in ICH Countries

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 1 Issue: 3 Year: 2014 Page: 169-175
Author(s): Venkatesh Madhugiri Prakash,Chethan Kumar Reddy,Pramod Kumar Teggin Math

Mini-Review Article

An Overview and Membership Process of PIC/S and ICH and itsRequirement for Global Regulatory Harmonization of Drugs

Journal: Current Drug Therapy
Volume: 19 Issue: 1 Year: 2024 Page: 1-12
Author(s):

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

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

Review Article

Endothelial Progenitor Cells as a Therapeutic Approach for Intracerebral Hemorrhage

Journal: Current Pharmaceutical Design
Volume: 23 Issue: 15 Year: 2017 Page: 2238-2251
Author(s): Juan Pías-Peleteiro,Francisco Campos,María Perez-Mato,Esteban Lopez-Arias,Manuel Rodriguez-Yanez,Jose Castillo,Tomas Sobrino

Quality by Design (QbD) Approach in Pharmaceuticals: Status, Challenges and Next Steps

Journal: Drug Delivery Letters
Volume: 5 Issue: 1 Year: 2015 Page: 2-8
Author(s): Lalit Singh,Vijay Sharma

Review Article

Exploring Optic Nerve Axon Regeneration

Journal: Current Neuropharmacology
Volume: 15 Issue: 6 Year: 2017 Page: 861-873
Author(s): Hong-Jiang Li,Zhao-Liang Sun,Xi-Tao Yang,Liang Zhu,Dong-Fu Feng

Mini-Review Article

Overview of Periodic Safety Update Reports: Where Have We Reached?

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 7 Issue: 1 Year: 2020 Page: 4-11
Author(s): Ruchika Sharma,Kamal Kant,Anoop Kumar

The Regulation of Pharmacogenomics-based Drugs and Policy Making

Journal: Current Topics in Medicinal Chemistry
Volume: 4 Issue: 1 Year: 2004 Page: 1453-1458
Author(s): Amalia M. Issa

Review Article

An Exhaustive Review on Recent Trends in Analytical Methods: DevelopmentStrategies and Recent Applications

Journal: Current Indian Science
Volume: 2 Issue: 1 Year: 2024 Page: 1-14
Author(s):

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