Parenteral Dosage Form Development: Technical Challenges and Regulatory Requirements
Parenteral dosage forms account for approximately 40% of new drug product approvals. This paper summarises the various types of parenteral dosage forms routinely encountered in drug development and the main Formulation and manufacturing challenges that are likely to be faced e.g. achieving the required concentration of the drug/drug solubility, stability and sterility (including sterility testing, Bacterial Endotoxin Testing, Container Closure Integrity testing and preservative effectiveness testing).
