Once a parenteral product has been shown to be safe and effective, specifi cations need to be developed to ensure consistent product performance across batches and throughout the shelf life of that product. This in turn necessitates an appreciation of the physiological variables and critical quality attributes that infl uence product performance. The assessment of the critical quality attributes and manufacturing processes of new drugs provides the basis for establishing these important quality standards. This chapter provides an overview of the questions and background information that regulators of human or veterinary parenteral dosage forms may consider when establishing the criteria that will ensure repeatable product quality and performance.
IntroductionThe evolution of parenteral extended release platforms pushes the bounds of our understanding of host physiology, pharmaceutical technology, and the regulatory sciences. In human medicine, these ingenious formulations ensure patient compliance, minimize undesirable fl uctuations in systemic drug concentrations, and can minimize the generalized systemic side effects associated with the administration of highly