Vol 13 No 2 (2025): VOLUME 13, ISSUE 2, 2025 | International Journal of Drug Regulatory Affairs

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Research

Acute Toxicity Study of Seed-Based Polymers in Wistar Rats: Evaluation of Safety Profile

Subhash Patil, Rakesh Kumar Jat

Pages 52-59
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.757

Review

Comparison of post approval changes & requirements of US, Brazil & Mexico

Dharavi Patel, Abhishek Patel, Zuki Patel, Maitreyi Zaveri

Pages 1-6
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.741
Regulatory framework for fast track approval of Drugs in different countries

Vasavi Pachika, Gilla Manya Raj, Vijaya Sindhuri Gopu

Pages 7-16
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.751
Drug Patent, Regulatory Exclusivity, and other protection rights (PTA & PTE and SPC) in Pharmaceuticals Development in US and Europe

Rabab Abdo Mohamed Fadlemula

Pages 17-24
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.753
Development and Registration of Drug Product across the various Regulatory Authorities (India, US, Europe, Australia, Japan)

Jayita Pal, Arijit Manna, Sohil Ahmed, Ananya Chandra, Jaydip Ray

Pages 25-42
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.755
Non-Clinical In-vitro and In-vivo Studies in Drug Development

Abdul Mannan, Tasneem Rasheed, Zoya Nousheen

Pages 43-51
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.756
Approval Trends of Recombinant DNA (r-DNA) Therapeutics in India: A Five- Year Review

Urmila Dwivedi, Priti Mehta, Shikha Patel

Pages 60-72
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.760
Artificial Intelligence in Regulatory Compliance: Transforming Pharmaceutical and Healthcare Documentation

Anjaneyulu Muppalla, Beena Devi Maddi, Nagabhushanam V Maddi

Pages 73-80
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.764
Medical Device Regulations in the US, Europe and India: A Boon or a Barrier for the Pharmaceutical Industry?

Divyadarshini Rajeshkumar, Sowmya Cherukuri

Pages 81-88
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.765
Harmonization of E-Labelling (Electronic Patient Information Leaflet) in Pharmaceuticals: A Global Perspective

Shabeena Sulthana Shaik, Sri Pujitha Dhullipala, Beena Devi Maddi, Nagabhushanam Maddi

Pages 89-96
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.766
An Overview of the Allopathic Drug Registration Process and Requirements in Ghana

Gaurav Bharti, Dinesh Bhandari

Pages 97-104
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i2.767