Vol 12 No 2 (2024): VOLUME 12, ISSUE 2, 2024 | International Journal of Drug Regulatory Affairs

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Research

Experience of Health professionals in the implementation of Clinical trials of Traditional Herbal Medicines: A cross-sectional study in Mali

Aboubacar SANGHO, Daniel Dori, Kampadilemba Ouoba, Oumar Sangho, Assitan Kaloga, Rokia Sanogo, Rasmané Semdé

Pages 8-14
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.659

Review

Regulatory and Quality Compliance of Oncology Products – A Global perspective

Kartik Gadhe, Utkarsh Mishra, Niranjan Kanaki, Vinit Movaliya, Shrikalp Deshpande, Maitreyi Zaveri

Pages 1-7
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.656
A Review on various aspects of Regulatory Affairs

Swaranjali Pore, Jeevan Deshmukh, Shivani Biskite, Snehal Jadhav, Akshata Moharekar, Ankita Gurav

Pages 15-22
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.664
The Shift Towards Generic Medicine: A Pragmatic Approach by Indian Doctors

Chandra Prakash Sharma, Pankaj Kumar Gogoi, Satyajit Mishra, Pooja Sundriyal

Pages 23-26
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.665
A Comparative Study on Regulatory Requirements for Pharmaceutical and Biological Product registration in ASEAN and Asia Pacific Region for Parenteral Dosage Form

Zeel Shah, Maitreyi Zaveri, Shrikalp Deshpande

Pages 27-36
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.669
Regulatory Frameworks for Integrated Medicine Management in USA, Europe, Japan, and China

Sanyam Gandhi, Omvir Sigh, Akhilesh Tiwari, Prafulla Apshingekar, Sachin Jain, Vikas Jain, Pradeep Pal, Amber Vyas

Pages 37-45
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.672
Dossier submission in the UK after Brexit

Bhavika Patel, Niranjan Kanaki, Bhavik Joshi, Maitreyi Zaveri

Pages 46-57
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.674
Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines

Devanshi Shah, Vinit Movaliya, Shruti Kharidia, Maitreyi Zaveri

Pages 58-64
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.675
Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil

Helly Kuveria, Zuki Patel, Manvendra Raval, Maitreyi Zaveri

Pages 65-72
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.676
OTC drug filing and review process in the US

Priyal Nayi, Maitreyi Zaveri, Dhaval Sheth, Niranjan Kanaki

Pages 73-79
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v12i2.677