Search Result "CHMP"

Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals

Journal: Current Drug Safety
Volume: 5 Issue: 4 Year: 2010 Page: 287-292
Author(s): Isabel C. Buttel, Katrin Voller, Christian K. Schneider

Dissecting the Role of K61/K59 Residue in VPS4 Functions

Journal: Protein & Peptide Letters
Volume: 23 Issue: 6 Year: 2016 Page: 518-524
Author(s): Luca Cesaro,Marta Toffoletto,Arianna Calistri,Mauro Salvi

Therapeutic Monoclonal Antibodies: Strategies and Challenges for Biosimilars Development

Journal: Current Medicinal Chemistry
Volume: 19 Issue: 2 Year: 2012 Page: 4445-4450
Author(s): Begona Calvo, Leyre Zuniga

Review Article

Risk Assessment and Monitoring of Antibody Responses to Biosimilars in Chronic Inflammatory Diseases

Journal: Current Pharmaceutical Design
Volume: 23 Issue: 44 Year: 2017 Page: 6739-6745
Author(s): Iris Detrez,Ann Gils

Safety and Tolerability of Agomelatine: Focus on Hepatotoxicity

Journal: Current Drug Metabolism
Volume: 15 Issue: 7 Year: 2014 Page: 694-702
Author(s): Maximilian Gahr,Wolfgang Kratzer,Michael Fuchs,Bernhard J. Connemann

Review Article

Kynurenine System and Multiple Sclerosis, Pathomechanism and Drug Targets with An Emphasis on Laquinimod

Journal: Current Drug Targets
Volume: 19 Issue: 7 Year: 2018 Page: 805-814
Author(s): Zsofia Majlath,Adam Annus,Laszlo Vecsei

Review Article

Biomimetic Approaches for Targeted Nanomedicine: Current Status and Future Perspectives

Journal: Current Drug Therapy
Volume: 14 Issue: 1 Year: 2019 Page: 3-15
Author(s): Jaya Agnihotri,Priyanka Maurya,Shobhna Singh,Shubhini A. Saraf

Review Article

Comparison of Regulatory Requirements for Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 7 Issue: 1 Year: 2020 Page: 37-44
Author(s): Shivani Jani,Nilesh Patel,Urvi Chotaliya,Ashok Patel

Review Article

Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of theirDetection, Mechanisms, and Regulatory Approaches

Journal: Current Topics in Medicinal Chemistry
Volume: 24 Issue: 6 Year: 2024 Page: 503-522
Author(s): Mahesh B. Palkar,Bhupendra G. Prajapati

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

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