International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  A comparison of the drug approval process in the united states and canada

  • Author: Sylvia Botros, Mina Botros, Nancy Botros
  • DOI: 10.22270/ijdra.v10i2.514

• A comprehensive study on counterfeit medicine and its prevention in India through its regulatory approach

  • Author: Suryaprakash Singh, Priyanka Gupta
  • DOI: 10.22270/ijdra.v10i2.515

• Assessment of regulatory requirements and filing procedure of drug master file for Brazil, Europe and South Africa

  • Author: Riya Patel, Kunal R. Girase, Venkateshwara T. Rao, Amit A. Patel, Ravish J. Patel
  • DOI: 10.22270/ijdra.v10i2.517

• A comparative study of biologic regulation in US, Canada, Australia, Europe and Singapore

  • Author: Yesha Patel, Amit A. Patel, Ravish J. Patel
  • DOI: 10.22270/ijdra.v10i2.518

• Comparison of dissolution profile for immediate-release dosage form for US and Europe

  • Author: Shivam Kanojiya, Neel Patel, Ravish J. Patel, Amit A. Patel
  • DOI: 10.22270/ijdra.v10i2.519

• Regulatory perspective of drug repurposing: Methods, regulatory pathways and hurdles

  • Author: Sonal Verma, Khushboo Vaghela, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v10i2.520

• Analysis on the registration and review system ot emergency medical devices in China and Abroad in the context ot Covid-19

  • Author: Yiming Xu, Mingyang Wu, Wei Chen, Siyi Ge, Yi Liang
  • DOI: 10.22270/ijdra.v10i2.522

• Bioequivalence requirements of pharmaceutical products in US, Europe and Australia

  • Author: Nishi Patel, Jimesh Shah, Amit A. Patel, Ravish J. Patel
  • DOI: 10.22270/ijdra.v10i2.524

• Registration of health products for human use: Niger republic case (from January 2018 to December 2020)

  • Author: Mahaman Rabiou Mamane Ibrahim, Ousmane Abdoulaye, Rakia Abdou Bagougou, Fatima Guiet Mati, Mahamadou Oudou Mossi Maiga, Hamidou Harouna, Mahaman Laouali Harouna Amadou, Kassoum Jataou Bahari, Nouhou Hama Aghali, Habsatou Mindaoudou, Bachir Illo, Barira Dan Nouhou
  • DOI: 10.22270/ijdra.v10i2.526

• Regulations on herbal products in India, united states and european union: A review

  • Author: Nirav Kumar Sapoliya, Mamta B. Shah
  • DOI: 10.22270/ijdra.v10i2.528

• Ai models predicting risk of cardio vascular diseases - the limitations, challenges and necessity for regulatory framework

  • Author: Vyshnavi Belidhe, Suha Maryam, Srivani Siddala, Divya Chinthamalla, Chandrakanth Garela, Jithan Aukunuru Venkata, Vidya Sagar Jenugu
  • DOI: 10.22270/ijdra.v10i2.529

• Strengthening veterinary pharmacy regulations through the harmonization process in the Uemoa region: The case of Niger and Cote d'ivoire

  • Author: Fatima, Sandra Wotsa Vidjro, Kampadilemba Ouoba, Ramatou Moumouni, Serge Antoine Amari, Jean-Yves Pabst
  • DOI: 10.22270/ijdra.v10i2.533

• Challenges and future of pharm D (doctor of pharmacy) profession: Promising career but with some reforms

  • Author: Rishitha Kalchetty, Priyanka Lone, Chandi Priya Bonaboina, Sravani Rapher, Laya Sree Panugantisira, Resika Kanukuntla, Ravi Kumar Badhavath, Madhusudhan Boddu, Jithan Aukunuru Venkata, Vidya Sagar Jenugu
  • DOI: 10.22270/ijdra.v10i2.535

• RESEARCH ARTICLE

  Clinical trial agreement - Eliminate legal problems when conducting clinical trials in Germany

  • Author: Christoph Gerst, Christina Geringer, Thomas Voigt, Raees Ahmed
  • DOI: 10.22270/ijdra.v10i2.539

• REVIEW ARTICLE

  Oncology drugs: Evolution, comparative study of global drug regulatory approval process and various measures to improve availability and accessibility

  • Author: Shagun Sharma, Khushbu Sharma, Pooja Verma, Shivali Rahi, Arpana Rana
  • DOI: 10.22270/ijdra.v10i2.542

• Comparative analysis of new drugs and clinical trial rules 2019 and its impact on approval process of oncology drugs

  • Author: Shagun Sharma, Khushbu Sharma, Pooja Verma, Shivali Rahi, Arpana Rana
  • DOI: 10.22270/ijdra.v10i2.543