The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
|Articles|October 2, 2018
AMRI
With locations in North America, Europe, and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Drug Discovery, Development, Analytical Services, API Manufacturing, and Drug Product.
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AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe, and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Drug Discovery, Development, Analytical Services, API Manufacturing, and Drug Product. Discover our expert solutions at amriglobal.com
26 Corporate Circle, Albany, NY 12203, USA
tel. 518.512.2000
Customerservice@amriglobal.com
AAPS Booth Number: 1809
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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