Solid-State Method Development & Validation

Solid oral dosage drugs typically require knowledge and control of the solid form (e.g., polymorph, hydrate, solvate, co-crystal, amorphous) before the final formulation is developed. The physical form of the drug affects the properties and overall performance (e.g., solubility, bioavailability, stability and purity) for the drug product used by patients. In many cases, it is necessary to have a solid form specification for the drug substance throughout most of the manufacturing process. This webinar will show how a properly chosen, developed and validated method for assessing the solid state of the drug substance can be done efficiently in a phase-appropriate manner.

Register for this webinar to learn about choosing and developing methods for assessing the solid state of oral drugs.

Speaker

Dr. Patrick Tishmack, General Manager, Curia (formerly AMRI)

Dr. Patrick Tishmack is currently the General Manager of Curia’s (formerly AMRI) well-known solid form drug development and analytical site. He was previously the director of the analytical development group, which developed and validated hundreds of solid-state methods for drug substances and drug products.

Dr. Tishmack received his Ph.D. in biochemistry from Purdue University specializing in NMR structural determination of large molecules. He subsequently did his post-doctoral work in Industrial and Physical Pharmacy at Purdue University studying solid-state properties of materials within solid oral drug formulations.

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