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Vol 9 No 2 (2021): VOLUME 9, ISSUE 2, 2021
Review
Regulatory procedures for emergency approval of medical products by regulatory agencies
G HariCharan, Kishore Kumar Ramoju, Suhana S, Yamini Lindait
Pages 1-5
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DOI
10.22270/ijdra.v9i2.459
FDA's drug regulatory pathways, its development strategies and regulatory considerations
Iva Dhulia, Himani Patel, Narendra Chauhan, Nidhi Pardeshi
Pages 6-15
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DOI
10.22270/ijdra.v9i2.460
Regulatory aspects for competitive Generic Therapies in USA
Himani Patel, Iva Dhulia, Umesh Dobariya, Nidhi Pardeshi, Yogesh Katariya
Pages 16-19
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DOI
10.22270/ijdra.v9i2.463
Interview Questions on ANDA filing
Rajkumar Gupta
Pages 20-25
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DOI
10.22270/ijdra.v9i2.464
Overview on Biopharmaceutics Classification System (BCS) based biowaiver requirements in African countries
Nidhi Sagar, Iva Dhulia, Himani Patel, Umesh Dobariya, Sandip Sarvaiya
Pages 26-29
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DOI
10.22270/ijdra.v9i2.465
Current regulations for Herbal Medicines in India
Saloni Singh, Vikesh Kumar Shukla
Pages 30-34
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DOI
10.22270/ijdra.v9i2.466
Registration Process of Medical Devices in CIS Countries
Ayesha bi Shaik, G. Ramakrishna
Pages 35-42
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DOI
10.22270/ijdra.v9i2.468
Strategic Intellectual Property Management and spin offs during Medical Device Innovation and commercialisation
Suchita Markan
Pages 43-51
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DOI
10.22270/ijdra.v9i2.469
Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe
Rajdeep G. Makwana, Kuldeep V. Desai, Vaibhav Kikani, Maulikkumar D. Vaja
Pages 52-65
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DOI
10.22270/ijdra.v9i2.470
Indian Active Pharmaceutical Ingredient (API) Industry- An overview on Challenges, Opportunities & Regulatory prerequisites
Shefali Singh, Harvinder Popli
Pages 66-76
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DOI
10.22270/ijdra.v9i2.471
Nitrosamine Impurities: Origin, Control and Regulatory Recommendations
Umesh Dobariya, Narendra Chauhan, Himani Patel, Nidhi Pardeshi
Pages 77-80
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DOI
10.22270/ijdra.v9i2.472
Liposome Characterization, Applications and Regulatory landscape in US
Amit Kumar, Madhu Gupta, Simran Braya
Pages 81-89
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DOI
10.22270/ijdra.v9i2.474
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Online ISSN: 2321-6794
Print ISSN: 2321-7162
CODEN (CAS-USA): IJDRAF
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