Actd regulatory requirements for approving an anticancer drug (thioguanine)
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, updat ed, 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 Requirement s, 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 it ems. It will assist in comprehending the documentation needs for drug registration in Myanmar.
Authors
- Sreerama Rajasekhar (ORCID: https://orcid.org/0000-0002-2287-2286)
- Audinarayana Nelavala
- D Jothieswari
- Yasmin Asraf
- G Neelima
Publication Details
- Journal
- International Journal of Clinical Pharmacokinetics and Medical Sciences
- Published
- 2024-10-01
- DOI
- https://doi.org/10.26452/ijcpms.v4i4.665
- Primary Topic
- Economic and Financial Impacts of Cancer
- Type
- article
- Field-Weighted Citation Impact
- 0.00