Pharmaceutical Technology
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
Pharmaceutical Technology - PharmTech
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
AAPS PharmSci 360 2024: Predictive Models for Poorly Soluble …
2024年10月10日 · As a preview of what’s to come at this year’s AAPS PharmSci 360, being held Oct. 20–23, 2024 in Salt Lake City, Utah, Pharmaceutical Technology® sat down with Niloufar …
What Does the FDA's Recent Update of the Nitrosamine Guidance …
2024年10月23日 · In September 2024, the much-anticipated update to FDA’s Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs was published (1). This update is …
FDA Releases Guidance on Accelerated Approvals
2024年12月6日 · FDA announced a draft guidance on Dec. 5, 2024 that explains the procedures and criteria for the agency’s accelerated drug approval for serious conditions.
QRM, Knowledge Management, and the Importance of ICH Q9(R1) …
2024年7月8日 · Editor’s Note: This article was peer-reviewed by Pharmaceutical Technology®’s Editorial Advisory Board. Submitted: January 20, 2024 Accepted: April 10, 2024. While the …
The ICH Q9 Revision and a Renewed Focus on Quality Risk
2023年12月2日 · The new revision of ICH Q9 was timely, as the pharmaceutical industry had spent many years since the original version was published in 2005 trying to establish the look …
Understanding the Value of Excipient Grade - pharmtech.com
2024年9月10日 · Excipients commonly make up the largest proportion of many drug dosage forms, performing specific functions, such as modifying API release, enhancing drug stability, …
CPHI Research Forecasts Growth for Biotech, Pharma Markets in …
2024年10月8日 · The 2024 CPHI Annual Report, a survey of more than 280 pharmaceutical industry executives from more than 40 countries, is forecasting an increase in biotech capital …
The Basics of Aseptic Processing - PharmTech
2021年10月2日 · Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.