Search Result "dossier"


Review Article

Comparative Study of Generic Drug Registration Requirements for Dossier Submission in African Region-Kenya, Ghana, Nigeria, and Botswana

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 3 Issue: 2 Year: 2016 Page: 71-81
Author(s): Nandini Warier, Priti Mehta

Review Article

A Comparative Study of Marketing Authorization of Drug Eluting Coronary Stents (DES) in India and Developed Countries (USA & EU)

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 4 Issue: 3 Year: 2017 Page: 166-174
Author(s): Rohin Sethi,Harvinder Popli

Review Article

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 7 Issue: 3 Year: 2020 Page: 162-176
Author(s): Kapil Pihwal,Neelam Pawar,Sheikh Aamir,Mohammad Shahbaz Alam,Vikas Rathee

Review Article

Regulatory Requirements and Comparison of Approval of New and Generic Drugs in the United States of America and Japan: Implication for Future Strategies

Journal: Applied Drug Research, Clinical Trials and Regulatory Affairs
Volume: 8 Issue: 1 Year: 2021 Page: 32-47
Author(s): Paramjeet Malik,Neelam Pawar,Kavita Bahmani

Enhanced Globalization and Speed to Market for Innovative Medicines

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 2 Issue: 3 Year: 2015 Page: 176-185
Author(s): Leticia Delgado-Herrera, Natalie Boone, Judy Kannenberg, Marcel van Gelderen, Keiichirou Ogawa, Mary Beth Blauwet, Marlowe J Schneidkraut, Sabine Agena, Raymond van Aarle, Yosuke Kubota, Marjan van der Werf-Pieters, Ivanka Baaij, Salim Mujais

Research Article

An Audit of Black Box Warnings (BBWs) in the United States Food and Drug Administration (US-FDA) Database - A Five-Year Analysis

Journal: Current Drug Safety
Volume: 16 Issue: 0 Year: 2021 Page: 1-5
Author(s): Debdipta Bose,Nithya Gogtay,Tejusv Goel,Mahanjit Konwar

Review Article

Metallodrugs as Anticancer Chemotherapeutics and Diagnostic Agents: A Critical Patent Review (2010-2020)

Journal: Recent Patents on Anti-Cancer Drug Discovery
Volume: 16 Issue: 0 Year: 2021 Page: 1-13
Author(s): Eirini Fotopoulou,Ioannis Titilas,Luca Ronconi

Radionuclide Imaging in Drug Development

Journal: Current Pharmaceutical Design
Volume: 10 Issue: 2 Year: 2004 Page: 2907-2921
Author(s): Alan C. Perkins, Malcolm Frier

Research Article

Comparative Study of Regulatory Framework for Probiotics: Current Status and Future Recommendations

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 4 Issue: 2 Year: 2017 Page: 140-156
Author(s): Malika Arora,Ashish Baldi

Review Article

Information in United States Patents on works related to ‘Natural Fibers’: 2000-2018

Journal: Current Materials Science
Volume: 12 Issue: 1 Year: 2019 Page: 4-76
Author(s): Krittirash Yorseng,Mavinkere R. Sanjay,Jiratti Tengsuthiwat,Harikrishnan Pulikkalparambil,Jyotishkumar Parameswaranpillai,Suchart Siengchin,Marta M. Moure

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