Method Development and Method Validation are extremely important in the development of drug materials. Oftentimes this will require specific areas of expertise that may not be available within the confines of a company or research institution.
Published conpendia, or pharmacopeias that describe official test methods provide regulatory guidance for method development and method validation for many marketed drug products. Scientists working on investigational new drugs (IND’s), new drug applications (NDA’s) and abbreviated new drug applications (ANDA’s) do not have published compendia or pharmacopeias to reference. Furthermore, many of the analytical technologies currently being used to characterize API’s and excipients have not been sufficiently developed or validated for these materials.
Analytical tests such as Specific Surface Area, Particle Size, Particle Shape, and Porosity all have significant utility within pharmaceutical sciences. Many of the new molecules that are being developed today pose unique challenges and require additional physical characterization tools that may not have been a widely used in the past. In addition, many of these materials are difficult to disperse and are therefore poor candidates for traditional technologies for particle size distribution. Some of these materials, due to poor solubility, are processed into nanoparticles resulting in additional physical characterization challenges. Don’t let your lack of knowledge in alternate physical characterization technologies stop you from uncovering a solution to your quality control needs.
Do you have a new material that you are finding difficult to characterize with your “in house” technologies? Are you spinning your wheels, wasting valuable time and resources trying to develop a robust analytical method?
Micromeritics Pharmaceutical Services can be entrusted with your most sensitive projects for method development and validation. Projects that oftentimes take months and significant expense and resources to develop “in house” can be outsourced to MPS for a fraction of the time and cost. The resulting product of our service is a developed and validated method delivered to you in a matter of days. Everything is done in a GMP environment that will provide you with science and technology based analytical testing desired by the FDA increasing your chances in a seamless submission.