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Vol 12 No 1 (2024): VOLUME 12, ISSUE 1, 2024
Research
Analysis of the conditions for the creation of pharmaceutical university spin-offs within a public university in Burkina Faso
Daniel DORI, Sonia Gampoa NASSOURI, Siéssima Lawakilia Natacha Tchaida Martine TOE DJIGUIMDE, Raogo OUEDRAOGO, Rasmané SEMDÉ
Pages 40-47
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DOI
10.22270/ijdra.v12i1.651
Quality of examination gloves in health facilities in Addis Ababa, Ethiopia
Yisihak Abraham Mehari, Yemane Berhane, Heran Gerba Borta, Kidanemariam Gebre Michael
Pages 48-53
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DOI
10.22270/ijdra.v12i1.652
Review
Nitrosamine Contamination in Pharmaceuticals: Regulatory Perspectives and Control Strategies of USFDA, EMA & HC
Nidhi Pardeshi, Vijay Satapara, Kajal Patel
Pages 1-8
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Abstract
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DOI
10.22270/ijdra.v12i1.624
Regulatory requirement for Medical Devices
Uthanthi Thamizhselvi Umapathi, Vijay Vijayakumar, Sivakumar Muthusamy, Vijayakumar Arumugam Ramamurthy, Deepa Natarajan
Pages 9-19
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DOI
10.22270/ijdra.v12i1.636
Drug Recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023
Nikita Varshney, Vijay Bhalla, Manish Gupta
Pages 20-23
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DOI
10.22270/ijdra.v12i1.645
Dosage form Design: From concept to Compliance - Navigating Regulatory Standards and Patient needs
Naushad Ahmed, Vivekanand Prajapati, Priyanka Mishra, N T Pramathesh Mishra
Pages 24-35
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DOI
10.22270/ijdra.v12i1.647
The Regulatory Affairs Automation tools used in the Pharmaceutical Industry: An overview
Kumar Chandrasekaran, T M Pramod Kumar, V Balamuralidhara
Pages 36-39
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DOI
10.22270/ijdra.v12i1.649
Technical reasons for delay and denial of regulatory approval of Initial applications for (Abbreviated) New Drugs filed by Indian Companies by USFDA, 2005-2022
Nikita Varshney, Vijay Bhalla, Manish Kumar Gupta
Pages 54-60
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DOI
10.22270/ijdra.v12i1.653
Overview of Post-approval Submissions Management in US, Europe and Canada
Charmi Patel, Richa Patel, Niranjan Kanaki, Vinit Movaliya, Shrikalp Deshpande, Maitreyi Zaveri
Pages 61-69
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DOI
10.22270/ijdra.v12i1.654
Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)
Nishi Patel, Hardik Prajapati, Navin Joshi, Vinit Movaliya, Niranjan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri
Pages 70-82
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DOI
10.22270/ijdra.v12i1.655
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Online ISSN: 2321-6794
Print ISSN: 2321-7162
CODEN (CAS-USA): IJDRAF
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