Search Result "pre-market approvals"


Post-Approval Changes in Pharmaceuticals: Regulatory Perspectives in Europe

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

FDA Approval for Phytochemicals in the Treatment of Cancer

Ebook: Phytonutrients in the Treatment of Gastrointestinal Cancer
Volume: 1 Year: 2023
Author(s):
Doi: 10.2174/9789815049633123010006

The First Approved Agent in the Glitazar’s Class: Saroglitazar

Journal: Current Drug Targets
Volume: 15 Issue: 2 Year: 2014 Page: 151-155
Author(s): Ritesh Agrawal

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

Review Article

Current Regulatory Framework and Challenges for the Approval of ComplexGenerics in the US and the EU

Journal: Current Indian Science
Volume: 2 Issue: 1 Year: 2024 Page: 1-17
Author(s):

Rituximab The First Monoclonal Antibody Approved for the Treatment of Lymphoma

Journal: Current Pharmaceutical Biotechnology
Volume: 1 Issue: 1 Year: 2000 Page: 1-9
Author(s): A. J. Grillo-Lopez, C. A. White, B. K. Dallaire, C. L. Varns, C. D. Shen, A. Wei, J. E. Leonard, A. McClure, R. Weaver, S. Cairelli, J. Rosenberg

Review Article

Pharmaceutical Market Access in Latin America: Analyzing Approval Requirements in Three Key Nations: Ecuador, Dominican Republic, and Nicaragua

Journal: Applied Drug Research, Clinical Trials and Regulatory Affairs
Volume: 10 Issue: 0 Year: 2024 Page: 1-18
Author(s):

Review Article open access plus

A Systematic Analysis of Physicochemical and ADME Properties of All Small Molecule Kinase Inhibitors Approved by US FDA from January 2001 to October 2015

Journal: Current Medicinal Chemistry
Volume: 24 Issue: 29 Year: 2017 Page: 3159-3184
Author(s): Zhihong O`Brien,Mehran F. Moghaddam

Syntheses of FDA Approved Integrase Inhibitor HIV Drugs and Improved Manufacturing using Flow Processing

Ebook: Frontiers in Clinical Drug Research: HIV
Volume: 4 Year: 2019
Author(s): Omobolanle Janet Jesumoroti,Faith Akwi,Paul Watts
Doi: 10.2174/9781681085265119040005

How New Drugs are Investigated

Ebook: Medicinal Chemistry - Fusion of Traditional and Western Medicine
Volume: 1 Year: 2013
Author(s): Robert E. Smith
Doi: 10.2174/9781608051496113010010

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