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March 15, 2023
Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.
By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
March 03, 2023
The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.
This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.
March 02, 2023
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.
February 21, 2023
In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.
February 13, 2023
After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.
February 03, 2023
Harmonization of global regulations fosters innovation and ensures quality medicines.