The Role of Excipients in Determining Nitrosamine Risks for Drug Products
We are glad to present our new webinar in collaboration with our partner Shin-Etsu:
The Role of Excipients in Determining Nitrosamine Risks for Drug Products
You will see two interesting presentations:
- Dr. Mike Tobyn: The role of excipients in determining-Nitrosamines risks for drug products
- Dr. Shingo Kikuchi : A Rapid Analytical Method for Nitrite Determination in Cellulose based Excipients
Your key learnings will be:
- Understanding the impact of excipients on generation of N-Nitrosamines (NDMA) in final drug product from a risk assessment point of view.
- Key considerations during the drug product risk assessment
- Role and source of nitrites in excipients
- Contribution of excipients suppliers
Date & Time & Timezone: Jun 17, 2025 04:00 PM in in Amsterdam, Berlin, Rome, Stockholm, Vienna
Speakers:
Dr. Mike Tobyn
Bristol Myers Squibb UK
Dr. Mike Tobyn: is an active member of the IPEC Europe Nitrosamines Group and member of the USP excipient test method group, contributing to advancements in quality standards and scientific innovation within the industry.
Since 2005 Mike is senior scientific director at Bristol Myers Squibb UK. With extensive expertise in pharmaceutical development and regulatory compliance, he is a recognized leader in the field.
Presentation Title: The role of excipients in determining-Nitrosamines risks for drug products
Dr. Shingo Kikuchi
Shin-Etsu Chemical
Dr. Shingo Kikuchi is a Technical Sales Manager at Shin-Etsu chemical. He obtained his doctoral degree in Pharmaceutical Sciences in 2012 at Hoshi University in Tokyo, Japan. He joined Shin-Etsu Japan in 2012 first as a researcher and then as technical sales manager in charge of Asia. His responsibilities included the development of solid dosage applications of Shin-Etsu cellulose ether excipients and the technical support of customers. In 2022 he relocated to Wiesbaden, Germany and joined the technical sales team.
Presentation Title: A Rapid Analytical Method for Nitrite Determination in Cellulose based Excipients
For more information & registration here:
Read more here
Source: Shin-Etsu & Pharma Excipients, website https://www.pharmaexcipients.com/webinars/