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Regulatory Pathways for Utilizing Biomarkers in Drug Development

Sep 16 2021

Biomarkers can play an integral role throughout the entire drug development lifecycle, and biomarkers can improve the success rate of a drug development program, bringing new therapies to market faster. Biomarkers can be employed for a variety of purposes, including monitoring the safety of a drug or therapy, as well as helping to determine if…

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The Twelve Principles of Green Chemistry: Reduce Derivatives

Aug 27 2021

The eighth principle of the Twelve Principles of Green Chemistry is reduce derivatives. Although derivatives and derivation reminds people of math in high school, we’re not talking about that. Unnecessary derivatization should be minimized or avoided if possible because such steps require additional reagents and can generate additional, unnecessary waste. Keep reading to learn about…

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The Importance of Synthetic Nicotine Testing for ENDS, Vape and Smokeless Tobacco Products

Aug 25 2021

All nicotine is not created equal. In fact, there are now two sources of nicotine finding their way into vape and smokeless tobacco products: natural nicotine, obtained from a plant source – typically from the tobacco plant, and synthetic nicotine, which is created via chemical synthesis. Synthetic nicotine is synthesized using a variety of chemicals…

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The Safety of ENDS Devices: The importance of screening, compliance and quality

Aug 23 2021

Dr. Derek Beauchamp, Senior Director of Client Solutions/ Consulting, Analytical Sciences at Avomeen, discusses the FDA’s premarket tobacco application (PMTA) along with the testing and data required to complete the application in this on-demand webinar presented at the VOXPO conference in 2021. Learn more about the entirety of the premarket tobacco application (PMTA) requires including which…

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It Starts With The Materials: Avomeen’s Cross Functional Team

Aug 20 2021

In our last “It Starts With Materials“ blog post, Christine Scheve discussed the importance of analytical chemistry in the development of medical devices. Analytical chemistry is crucial, and even the focus, in and around many research and development projects that Avomeen is working on, including an innovative approach to dealing with the opioid crisis that…

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Key Considerations for Residual Solvents Testing per Updated ICH Q3C Guidelines

Aug 16 2021

Organic solvents are used in the creation or manufacture of most drugs and/or pharmaceutical additives, and solvents that are not completely removed after processing by practical manufacturing techniques are classified as residual solvents. In May 2021, the International Council for Harmonization (ICH) announced an update to its residual solvents guidelines, establishing new permitted daily exposures…

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Living Our Values – Teamwork & Collaboration Spotlight: Nathan Blauw

Aug 13 2021

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles. The Teamwork & Collaboration award recognizes a member of our support staff for internal customer service, and the recipient is selected by an all-staff vote. This quarter, two of our staff members were…

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Controlling Dangerous Mycotoxins and Other Microbial Contaminants in Nicotine Products

Aug 11 2021

Extremely dangerous toxins, including mycotoxins and other microbial contaminants, have recently been found in a variety of nicotine products on the marketplace. These microbial toxins can cause long-term damage in both small and large dosages. Madison Moote, Avomeen’s Manager of Nicotine Products, discusses the impact of mycotoxins and other microbial contaminants when found in nicotine-containing…

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Living Our Values – Client Centricity Spotlight: Kim Dornes

Aug 9 2021

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles. The Client Centricity award recognizes a member of our client-facing team who consistently goes above and beyond to serve our clients. We’re getting to know Kim Dornes, who took home this award, in…

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Living Our Values – Teamwork & Collaboration Spotlight: Hayden Schaeffer

Aug 5 2021

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles. The Teamwork & Collaboration award recognizes a member of our support staff for internal customer service, and the recipient is selected by an all-staff vote. This quarter, two of our staff members were…

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