Profile

Dr. Mark Arnold, Ph.D., FAAPS

Owner and Principal,
Bioanalytical Solution Integration

Contact Details

Bioanalytical Solution Integration

My Content

1 to 4 of 4 total

FDA publishes on NAMs in JAMA

Posted By Mark Arnold 04-20-2026 16:10
Found In Egroup: Translational and Clinical Science Community \ view thread
More insights from the FDA on implementing new approach methodologies were just published in JAMA. https://jamanetwork.com/journals/jama/fullarticle/2848148?resultClick=1 #fda #NAM ------------------------------ Mark Arnold Ph.D., FAAPS Westampton, NJ [email protected] Bioanalytical Solution ...

FDA releases draft guidance on Establishing Impurity Specifications for Antibiotics

Posted By Mark Arnold 04-17-2026 09:30
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
AAPS normally doesn't have a lot of discussion on antibiotics, but for those who work in this space, the Agency just released a new draft guidance "Establishing Impurity Specifications for Antibiotics". From the announcement: "The draft guidance provides recommendations regarding the establishment ...

ICH releases presentation on M15 MIDD

Posted By Mark Arnold 04-09-2026 08:00
Found In Egroup: Translational and Clinical Science Community \ view thread
ICH just released a presentation on "M15: General Principles for Model-Informed Drug Development" It provides an overview of M15 and notes several times that additional training materials will be developed. You can access the 23 slides here: https://database.ich.org/sites/default/files/ICH_Step_4_ ...

EMA journal article "3Rs at the European Medicines Agency: Past and future activities"

Posted By Mark Arnold 03-27-2026 15:41
Found In Egroup: Translational and Clinical Science Community \ view thread
EMA has analyzed its data over the last 15 years in implementing the 3Rs and now in the context of NAM what has occured with new regulations and international harmonization efforts. The articles Abstract: "Driven by scientific advancements, the replacement, reduction and refinement of animal use (i.e. ...