Search Result "European Medicine Agency (EMA)"


Review Article

Regulation and Challenges of Biosimilars in European Union

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 6 Issue: 3 Year: 2019 Page: 192-211
Author(s): Vikram,Aakash Deep,Manita

Review Article

Personalized Medicine and Medicinal Chemistry: Toward a Legal Framework in the European Union

Journal: Current Topics in Medicinal Chemistry
Volume: 18 Issue: 2 Year: 2018 Page: 2165-2173
Author(s): Aliuska Duardo-Sánchez,Iñigo De Miguel Beriain

Evaluation of Herbal Medicines: Value Addition to Traditional Medicines Through Metabolism, Pharmacokinetic and Safety Studies

Journal: Current Drug Metabolism
Volume: 15 Issue: 1 Year: 2014 Page: 942-952
Author(s): Roslyn Thelingwani, Collen Masimirembwa

Chemokine Receptor CCR5 Antagonist Maraviroc: Medicinal Chemistry and Clinical Applications

Journal: Current Topics in Medicinal Chemistry
Volume: 14 Issue: 1 Year: 2014 Page: 1504-1514
Author(s): Guoyan G. Xu, Jia Guo, Yuntao Wu

Research Article

Variability of Pharmacogenomics Information in Drug Labels Approved by Different Agencies and its Ethical Implications

Journal: Current Drug Safety
Volume: 16 Issue: 0 Year: 2021 Page: 1-7
Author(s): Müberra Devrim Güner,Perihan Elif Ekmekci,Berra Kurtoglu

Post-Approval Changes in Pharmaceuticals: Regulatory Perspectives in Europe

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 2 Issue: 2 Year: 2015 Page: 60-68
Author(s): Pankaj Kumar, Vibhu Yadav, Deepak Kaushik

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

Review Article

Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development

Journal: Current Medicinal Chemistry
Volume: 28 Issue: 0 Year: 2021 Page: 1-15
Author(s): Ildikó Csóka,Ruba Ismail,Orsolya Jójárt-Laczkovich,Edina Pallagi

From Traditional European Medicine to Discovery of New Drug Candidates for the Treatment of Dementia and Alzheimer's Disease: Acetylcholinesterase Inhibitors

Journal: Current Medicinal Chemistry
Volume: 20 Issue: 8 Year: 2013 Page: 976-983
Author(s): P. Russo, A. Frustaci, A. Del Bufalo, M. Fini, A. Cesario

Perspective

2020 FDA Drug-drug Interaction Guidance: A Comparison Analysis and Action Plan by Pharmaceutical Industrial Scientists

Journal: Current Drug Metabolism
Volume: 21 Issue: 6 Year: 2020 Page: 403-426
Author(s): Sirimas Sudsakorn,Praveen Bahadduri,Jennifer Fretland,Chuang Lu

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