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ANDA Regulatory Pathway: Q1/Q2 (Q3) Deformulation & Equivalence

Jul 6 2020

Deformulation, also known as reverse engineering, is a key part of generic pharmaceutical drug formulation and the abbreviated new drug application (ANDA) process. According to FDA’s Generic Drug Facts, “a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality,…

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Living Our Values – Scientific Excellence Spotlight: Khanh Ngo Courtney, Ph.D.

Jun 25 2020

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles, and the Scientific Excellence award recognizes a scientist who consistently develops and delivers scientifically advanced solutions. We’re getting to know Khanh Ngo Courtney, the recipient of this award, with a little Q&A: For…

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PMTA Trends in Rejections

Jun 24 2020

Premarket Tobacco Applications (PMTAs) Since Program Inception Since the Premarket Tobacco Application (PMTA) program was established in October 2014, approximately 417 Premarket Tobacco Applications have been submitted. A majority of these were in the summer of 2016. However, to date, only 15 PMTAs have been approved. According to the FDA, 85.2% of submitted PMTAs are…

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Living Our Values – Teamwork & Collaboration Spotlight: Haley Hamel

Jun 23 2020

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. Haley received a record number of votes –…

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A New Approach to Drug Delivery: Oral Thin Films

Jun 22 2020

Oral thin films (OTF) are a promising novel drug delivery system intended to deliver active therapeutic moieties locally or systemically in the oral cavity under the tongue, on the roof of the mouth, in the intestines, or while held in the mouth. OTF technologies enable fast or sustained release of the active substance which ensures…

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Living Our Values – Quality & Compliance Spotlight: Joel McAdams

Jun 19 2020

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles. The Quality & Compliance award recognizes a scientist who consistently demonstrates outstanding compliance and documentation, and the recipient is chosen by the Director of Quality Assurance. We’re getting to know Joel McAdams, who…

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Living Our Values – Personalized Service Spotlight: Amy Markowitz

Jun 17 2020

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles, and the Personalized Service award recognizes a scientist who goes above and beyond to exceed client expectations. We’re learning more about Amy Markowitz, the recipient of this award, in a Q&A session: For…

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5 Things You Can Do With ProteinSimple Maurice Capillary Electrophoresis

Jun 15 2020

1) Assess Charge Heterogeneity by cIEF (Capillary Isoelectric Focusing) Many proteins, including therapeutic ADCs, are post-translationally modified by glycosylation and phosphorylation, or undergo deamidation and oxidation that complicate the overall charge heterogeneity of the sample. Traditional techniques may not always be adequate to characterize such variants with sufficient resolution and sensitivity. The Maurice platform has…

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2020 Women in STEM Scholarship Spotlight: Vivian C.

Jun 1 2020

Avomeen is committed to supporting and helping to inspire the next generation of scientists and leaders in STEM. We’re privileged to have the opportunity to help ease some of the financial stress that comes with higher education. Our Women in STEM and Minorities in STEM Scholarship Program allows us to support undergraduates who are on…

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2020 Minorities in STEM Scholarship Spotlight: Sabrina K.

May 29 2020

Avomeen is committed to supporting and helping to inspire the next generation of scientists and leaders in STEM. We’re privileged to have the opportunity to help ease some of the financial stress that comes with higher education. Our Women in STEM and Minorities in STEM Scholarship Program allows us to support undergraduates who are on…

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