Preparing & submitting protocols to the drug administration
Training & supporting other personnel to ensure compliance with ICH regulations and local regulatory requirements
Evaluating risk and suggesting regulatory pathways for generic drugs
[ Apr 2021 – Jun 2023 ]
Trained the research team in pharmaceutical formulation, new product development, and lifecycle management of pharmaceutical products
Supported manufacturing and quality activities during the development and manufacture of marketed products
Designed dosage forms base on physicochemical properties of drug substances including solubility, pKa, impurities, and stability
Selected excipients, manufacturing methods, and equipment for various pharmaceutical dosage forms with regards to technical production requirements and pharmacological properties
Executed durability and stability studies to assess the quality of final products
A key member of the project: Research and synthesis of some hydroxamic acids as histone deacetylase inhibitors and antitumor agents, funded by the National Foundation for Science and Technology Development (Nafosted)
Participated in experimental data processing and writing journal manuscripts for publishing