Factors In Developing Injectable Drug Placebo Formulations For Pharmaceutical Clinical Trials

By Ryan Memmer and William Powers, Singota

Designed and conducted properly, placebo-controlled clinical trials can provide proof a new drug is effective. Proper and complete understanding of development practices for placebos is important to the execution and outcomes of clinical trials. This article highlights factors that pharmaceutical scientists must consider when formulating placebos for injectable drugs to ensure the reliability and validity of clinical trial outcomes.

Injectable drug placebo formulation can be accomplished by leveraging knowledge of the active product and then developing specifications that clearly define and quantify these characteristics, along with appropriate analytical methods. Physical appearance and handling properties, such as viscosity, appearance, color, and pH, must be specified. Methods must be identified and developed/qualified prior to any product development/testing activities.