Actd regulatory requirements for approving an anticancer drug (thioguanine)

Authors

  • Yasmin Asraf Department of Regulatory Affairs, Sri Venkateswara College of Pharmacy, Chittoor-517127, Andhra Pradesh, India.
  • Rajasekhar Sreerama Department of Pharmaceutical Chemistry, Sri Venkateswara College of Pharmacy, Chittoor-517127, Andhra Pradesh, India.
  • Audinarayana Nelavala Department of Pharmaceutics, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh, India.
  • G Neelima Department of Pharmaceutical Analysis, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh, India.
  • D Jothieswari Department of Pharmaceutical Analysis, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh, India

DOI:

https://doi.org/10.26452/ijcpms.v4i4.665

Keywords:

ACTD, Regulatory Affairs, Anticancer, Myanmar

Abstract

This work makes document handling safer and more accessible. It can manage even more complex papers in addition to all the benefits. Using this work, a composite document or papers from several different document sources and formats can be assembled, updated, and published. Each document is treated as a single, identically organized document. BMR, Process Validation Record, Stability Study (including Accelerated & Long Term Stability Study per Myanmar Zone Specification), Anticancer Drug Packing Requirements, and Certificate for Product Permission (covering all aspects from manufacturing to its packing & registration) are among the required documents. It offers reliable scientific methods for determining the effectiveness, safety, and quality of medicinal items. It will assist in comprehending the documentation needs for drug registration in Myanmar.

 

 

 

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Published

2024-10-02

How to Cite

Asraf, Y. ., Sreerama, R. ., Nelavala, A. ., Neelima, G. ., & Jothieswari, D. . (2024). Actd regulatory requirements for approving an anticancer drug (thioguanine). International Journal of Clinical Pharmacokinetics and Medical Sciences, 4(4), 14–24. https://doi.org/10.26452/ijcpms.v4i4.665

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Section

Original Article