International Journal of Drug Regulatory Affairs (IJDRA)

Table of Contents

• REVIEW ARTICLE

  Covering Global Pharmaceutical Regulations in a Quality System

  • Author: Siegfried Schmitt
  • DOI: 10.22270/ijdra.v6i3.257

• A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines

  • Author: M Saffiya Khatun, Jyothshna Devi Katamreddy, P Jayachandra Reddy
  • DOI: 10.22270/ijdra.v6i3.260

• Registration of Drug Product dossier application as per EU Guidelines

  • Author: Kondepati Bhavya, Jyothshna Devi Katamreddy, P Jayachandra Reddy
  • DOI: 10.22270/ijdra.v6i3.261

• Saxagliptin and Dapagliflozin for type 2 Diabetes mellitus: A Review

  • Author: Deepshi Ranjan, Akanksha Sharma, Ramesh Babu Bodla
  • DOI: 10.22270/ijdra.v6i3.264

• Drug approval process in US, Europe and India and its regulatory requirements: A Review

  • Author: Krishnasis Chakraborty, Kavita Yadav
  • DOI: 10.22270/ijdra.v6i3.266

• Regulatory overview of biosimilars in Europe

  • Author: Shailaja Pashikanti, V Jyothi Sri Durga, A.N.V.L. Sowmya
  • DOI: 10.22270/ijdra.v6i3.270

• Study the effects of Nipah Virus-A Review

  • Author: Dhiraj Kumar Singh, Rakhi Ahuja, Nagendra Kumar Singh
  • DOI: 10.22270/ijdra.v6i3.275