International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  Regulatory and quality compliance of oncology products - A global perspective

  • Author: Kartik Gadhe, Utkarsh Mishra, Niranjan Kanaki, Vinit Movaliya, Shrikalp Deshpande, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i2.656

• RESEARCH ARTICLE

  Experience of health professionals in the implementation of clinical trials of traditional herbal medicines: A cross-sectional study in Mali

  • Author: Aboubacar Sangho, Daniel Dori, Kampadilemba Ouoba, Oumar Sangho, Assitan Kaloga, Rokia Sanogo, Rasmane Semde
  • DOI: 10.22270/ijdra.v12i2.659

• REVIEW ARTICLE

  A review on various aspects of regulatory affairs

  • Author: Swaranjali Pore, Jeevan Deshmukh, Shivani Biskite, Snehal Jadhav, Akshata Moharekar, Ankita Gurav
  • DOI: 10.22270/ijdra.v12i2.664

• The shift towards generic medicine: A pragmatic approach by Indian doctors

  • Author: Chandra Prakash Sharma, Pankaj Kumar Gogoi, Satyajit Mishra, Pooja Sundriyal
  • 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

  • Author: Zeel Shah, Maitreyi Zaveri, Shrikalp Deshpande
  • DOI: 10.22270/ijdra.v12i2.669

• Regulatory frameworks for integrated medicine management in USA, Europe, Japan, and China

  • Author: Sanyam Gandhi, Omvir Sigh, Akhilesh Tiwari, Prafulla Apshingekar, Sachin Jain, Vikas Jain, Pradeep Pal, Amber Vyas
  • DOI: 10.22270/ijdra.v12i2.672

• Dossier submission in the UK after brexit

  • Author: Bhavika Patel, Niranjan Kanaki, Bhavik Joshi, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i2.674

• Comparative study of analytical method validation and process validation parameters as per ICH, EMA, WHO and ASEAN guidelines

  • Author: Devanshi Shah, Vinit Movaliya, Shruti Kharidia, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i2.675

• Overview and lifecycle management of generic pharmaceutical drugs in Mexico, Guatemala and Brazil

  • Author: Helly Kuveria, Zuki Patel, Manvendra Raval, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i2.676

• OTC drug filing and review process in the US

  • Author: Priyal Nayi, Maitreyi Zaveri, Dhaval Sheth, Niranjan Kanaki
  • DOI: 10.22270/ijdra.v12i2.677