Solid-State Method Development & Validation
About this webinar
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.
Who should attend
- Analytical R&D Chemists
- Solid-State Materials Chemists
- Pharmaceutical Development Scientists
- Physical Pharmacy Scientists
What you will learn
- Practical solid-state method development with several of the most common analytical techniques
- How to address the unique challenges of qualitative and quantitative methods for solid materials
- Regulatory guidelines for developing and validating methods
Featured Speakers
Dr. Patrick Tishmack
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.
Partner for this event
Curia
Curia is a global contract research, development and manufacturing organization, offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. Learn more at curiaglobal.com.
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