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Vol 6 No 3 (2018): VOLUME 6, ISSUE 3, 2018
Review
Covering Global Pharmaceutical Regulations in a Quality System
Siegfried Schmitt
Pages 1-4
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DOI
10.22270/ijdra.v6i3.257
A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines
Saffiya Khatun M, Jyothshna Devi Katamreddy, Jayachandra Reddy P
Pages 5-12
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DOI
10.22270/ijdra.v6i3.260
Registration of Drug Product dossier application as per EU Guidelines
Bhavya Kondepati, Jyothshna Devi Katamreddy, Jayachandra reddy P
Pages 13-23
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DOI
10.22270/ijdra.v6i3.261
Saxagliptin and Dapagliflozin for type 2 Diabetes mellitus: A Review
Deepshi Ranjan, Akanksha Sharma, Ramesh Babu Bodla
Pages 24-30
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DOI
10.22270/ijdra.v6i3.264
Drug approval process in US, Europe and India and its regulatory requirements: A Review
Krishnasis Chakraborty, Kavita Yadav
Pages 31-39
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DOI
10.22270/ijdra.v6i3.266
Regulatory overview of biosimilars in Europe
Jyothi Sri Durga Vanacharla, Shailaja Pashikanti, Sowmya A. N. V. L
Pages 40-44
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DOI
10.22270/ijdra.v6i3.270
Study the effects of Nipah Virus – A Review
Dhiraj Kumar Singh, Rakhi Ahuja, Nagendra Kumar Singh
Pages 45-52
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DOI
10.22270/ijdra.v6i3.275
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Online ISSN: 2321-6794
Print ISSN: 2321-7162
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