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International Journal of Drug Regulatory Affairs (IJDRA)
Year 2018, Volume-6, Issue-3 (September)
Print ISSN : 2321-2162
Online ISSN : 2321-6794

Table of contents

Review Articles

Covering Global Pharmaceutical Regulations in a Quality System
Siegfried Schmitt

A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines
M Saffiya Khatun, Jyothshna Devi Katamreddy, P Jayachandra Reddy

Registration of Drug Product dossier application as per EU Guidelines
Kondepati Bhavya, Jyothshna Devi Katamreddy, P Jayachandra Reddy

Saxagliptin and Dapagliflozin for type 2 Diabetes mellitus: A Review
Deepshi Ranjan, Akanksha Sharma, Ramesh Babu Bodla

Drug approval process in US, Europe and India and its regulatory requirements: A Review
Krishnasis Chakraborty, Kavita Yadav

Regulatory overview of biosimilars in Europe
Shailaja Pashikanti, V Jyothi Sri Durga, A.N.V.L. Sowmya

Study the effects of Nipah Virus-A Review
Dhiraj Kumar Singh, Rakhi Ahuja, Nagendra Kumar Singh

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