European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar ...
Biopharmaceutical developers should introduce risk-based, phase-appropriate characterization strategies for quality control ...
Automated quality control using rapid PCR assays is replacing 28-day culture tests, cutting biopharmaceutical lot release ...
As drug developers pursue increasingly complex therapies, traditional bioanalytical approaches are being put to the test. How ...
Several industry groups and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic ...
Discover how bioprocessing technology industrial applications expand as fermentation, membrane filtration, PAT, and ...
CluePoints, provider of leading statistical and AI-driven software solutions, has welcomed publication of its research providing ...
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released ...
Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...
In January, 1923, Lee Strasberg went to Al Jolson’s 59th Street Theatre to see “Tsar Fyodor Ivanovich,” a nineteenth-century Russian play about sixteenth-century Russian politics, performed, in ...
Defining Undertreatment and Overtreatment in Older Adults With Cancer: A Scoping Literature Review The literature search identified 100 relevant studies to inform the evidence base for this guideline.
Background Difference-in-differences is a method commonly used in population health research. It is based on assumptions that ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results