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|March 2, 2016
- Pharmaceutical Technology-03-02-2016
- Volume 40
- Issue 3
FDA GDUFA Testimony Presentation Slides
Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.
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Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.
Articles in this issue
over 10 years ago
Gaining Insight from Process Control Dataover 10 years ago
Phase-Appropriate GMPover 10 years ago
How Important is Data Integrity to Regulatory Bodies?over 10 years ago
Keynote Series Addresses Crucial Industry Issuesover 10 years ago
Polymorph Screening for Identification of Relevant Crystalline Formsover 10 years ago
Building Consensus for E&L Testing Standardsover 10 years ago
Multimode Microplate Reader Improves Sensitivityover 10 years ago
High-Pressure Ion Chromatography SystemAdvertisement
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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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