Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
News|Articles|April 2, 2010
- Pharmaceutical Technology-04-02-2010
- Volume 34
- Issue 4
Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach
The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.
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Please refer to the full online version of this article, located
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Tracking Solid-Dosage Equipmentover 16 years ago
Inside EDQM: The Role of the Pharmacopeia in a Globalized Worldover 16 years ago
More Questions than Answersover 16 years ago
Stay Current at INTERPHEXover 16 years ago
Unconventional Communicationover 16 years ago
The Effect of Overencapsulation on Disintegration and Dissolutionover 16 years ago
In the Spotlight April 2010over 16 years ago
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Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.
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.
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.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
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