International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

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

  • Author: Dharavi Patel, Abhishek Patel, Zuki Patel, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v13i2.741

• Regulatory framework for fast track approval of Drugs in different countries

  • Author: Vasavi Pachika, Gilla Manya Raj, Vijaya Sindhuri Gopu
  • DOI: 10.22270/ijdra.v13i2.751

• Drug Patent, Regulatory Exclusivity, and other protection rights (PTA, PTE and SPC) in Pharmaceutical Development in the United States and Europe

  • Author: Rabab Abdo Mohamed Fadlemula
  • DOI: 10.22270/ijdra.v13i2.753

• Development and Registration of Drug Product across the various Regulatory Authorities (India, US, Europe, Australia, Japan)

  • Author: Jayita Pal, Arijit Manna, Sohil Ahmed, Ananya Chandra, Jaydip Ray
  • DOI: 10.22270/ijdra.v13i2.755

• Non-Clinical In-vitro and In-vivo Studies in Drug Development

  • Author: Abdul Mannan, Tasneem Rasheed, Zoya Nousheen
  • DOI: 10.22270/ijdra.v13i2.756

• RESEARCH ARTICLE

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

  • Author: Subhash Yashwant Patil, Rakesh Kumar Jat
  • DOI: 10.22270/ijdra.v13i2.757

• REVIEW ARTICLE

  Approval Trends of Recombinant DNA (r-DNA) Therapeutics in India: A Five- Year Review

  • Author: Urmila Dwivedi, Priti Mehta, Shikha Patel
  • DOI: 10.22270/ijdra.v13i2.760

• Artificial Intelligence in Regulatory Compliance: Transforming Pharmaceutical and Healthcare Documentation

  • Author: Anjaneyulu Muppalla, Beena Devi Maddi, V Nagabhushanam Maddi
  • DOI: 10.22270/ijdra.v13i2.764

• Medical Device Regulations in the US, Europe and India: A Boon or a Barrier for the Pharmaceutical Industry?

  • Author: Divyadarshini Rajeshkumar, Sowmya Cherukuri
  • DOI: 10.22270/ijdra.v13i2.765

• Harmonization of E-Labelling (Electronic Patient Information Leaflet) in Pharmaceuticals: A Global Perspective

  • Author: Shabeena Sulthana Shaik, Sri Pujitha Dhullipala, Beena Devi Maddi, Nagabhushanam Maddi
  • DOI: 10.22270/ijdra.v13i2.766

• An Overview of the Allopathic Drug Registration Process and Requirements in Ghana

  • Author: Gaurav Bharti, Dinesh Bhandari
  • DOI: 10.22270/ijdra.v13i2.767