Search Result "FDA and EMA guidelines"
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
Update of Standard Practices for New Method Validation in Forensic Toxicology
Journal: Current Pharmaceutical Design
Volume: 23 Issue: 36 Year: 2017 Page: 5442-5454
Author(s): Sarah M.R. Wille,Wim Coucke,Thierry De Baere,Frank T. Peters
Regulatory Considerations for Generic or Biosimilar Low Molecular Weight Heparins
Journal: Current Drug Discovery Technologies
Volume: 9 Issue: 2 Year: 2012 Page: 137-142
Author(s): Alfredo Garcia-Arieta,Antonio Blazquez
Phase IV Studies: Some Insights, Clarifications, and Issues
Journal: Current Clinical Pharmacology
Volume: 13 Issue: 1 Year: 2018 Page: 14-20
Author(s): Bruno Mario Cesana,Elia Mario Biganzoli
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
Evaluation of Herbal Medicines: Value Addition to Traditional Medicines Through Metabolism, Pharmacokinetic and Safety Studies
Journal: Current Drug Metabolism
Volume: 15 Issue: 10 Year: 2014 Page: 942-952
Author(s): Roslyn Thelingwani,Collen Masimirembwa
Upcoming Drifts in Bio-similars
Journal: Current Reviews in Clinical and Experimental Pharmacology
Volume: 16 Issue: 1 Year: 2021 Page: 39-51
Author(s): Geeta Aggarwal,Manju Nagpal,Ameya Sharma,Vivek Puri,Gitika Arora Dhingra
Trends in the Analysis of Biopharmaceuticals by HPLC
Journal: Current Analytical Chemistry
Volume: 16 Issue: 1 Year: 2020 Page: 52-58
Author(s): Angela Tartaglia,Marcello Locatelli,Victoria Samanidou
Approved and Marketed Fast Dissolving/ Disintegrating Drug Products
Ebook: Current Advances in Drug Delivery Through Fast Dissolving/Disintegrating Dosage Forms
Volume: 1 Year: 2017
Author(s): Vikas A. Saharan,Anupama Singh,Vandana Kharb
Doi: 10.2174/9781681084596117010015
Artificial Intelligence in Drug Regulatory Submissions in India
Journal: Applied Drug Research, Clinical Trials and Regulatory Affairs
Volume: 9 Issue: 1 Year: 2022 Page: 58-68
Author(s): Vikesh Kumar Shukla,Manvi Kumar Mittal