Dissolution Method Development Guidance Using QbD

Quality by design (QbD) in the development of drug formulations is laid down as a requirement in the ICH Q8 guideline to assure product quality, reduce cost, and provide better regulatory oversight. QbD is not a new topic in the method development of dissolution testing, but it may be a new topic for you.

We want to provide you with an overview of how this area has evolved and especially what the authorities expect from your dissolution method development. Following this approach may also require a change in mindset and the style of working in your laboratory. Join us for a lively meeting and discussion of this topic.

Presenter: Karen Krauel-Göllner, PhD (Product Manager Dissolution, Agilent Technologies, Inc.)

Karen Krauel-Göllner is a registered pharmacist and holds a PhD in Pharmacy from the University of Otago, New Zealand. Karen has worked in various roles in the field of pharmaceutical development. For the last 10 years she has been working with Agilent Technologies and currently holds a position as product manager for dissolution systems.

Presenter: Ken Boda (Dissolution Product Specialist, Agilent Technologies, Inc.)

Ken joined Varian (now Agilent) in 2005 as an applications engineer and is now a dissolution product specialist. Prior to working at Agilent, he worked in pharma specializing in dissolution testing and method development. As a dissolution product specialist, Ken works with customers in determining the best systems for their needs and optimizing their workflows. He has also helped educate customers on dissolution science through webinars, the Dissolution Discussion Group, LinkedIn, and other channels.

Presenter: Bryan Crist (President, DissoAssist Consulting, Wilmington, NC, USA)

Bryan has been the president of DissoAssist consulting based in Wilmington, NC, USA since 2021. He provides consulting, coaching, and training services for dissolution and drug release in the pharmaceutical industry. Bryan is also an active member on various USP Expert Committees.

Previously, Bryan was a scientific affairs manager with Agilent Technologies located in Cary, North Carolina, USA. From 1997 to 2021, he focused on providing method and technical application support for dissolution and drug release testing in the pharmaceutical industry as well as working with VanKel, Varian, and eventually Agilent. Prior to 1997, Bryan supervised and managed pharmaceutical laboratories and performed analytical testing with Bristol-Myers Squibb, Merck, AAI, and Abbott Laboratories until he joined the dissolution equipment manufacturer VanKel.

Presenter: Vivian Gray (Founder VA Gray Consulting; Managing Director of Dissolution Technologies)

Vivian has spent the last 40+ years involved in all aspects of dissolution testing and evaluating new dissolution technology. At the United States Pharmacopeia, she enjoyed a long career serving first as a bench chemist, supervisor, and lastly as a liaison to various expert USP committees. In 1997, Vivian joined the DuPont-Merck Pharmaceuticals Company Analytical Research and Development Section as the head of the Dissolution Group. In 2002, she formed her own consulting business, V. A. Gray Consulting, Inc., in dissolution testing and related areas. In June 2003, she became managing director of Dissolution Technologies, a peer-reviewed journal dealing specifically with dissolution testing issues.