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Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process.
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.
Brüün has announced he will be leaving his role as CEO at the BPS and moving to a new role at the Royal College of Anaesthetists.
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this second piece, we discuss the challenges, legal implications and perceptions of cannabinoids.
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
SGS Life Sciences launches OneVision, a global digitalisation initiative to create a single, integrated network of testing laboratories.
Researchers have developed silica spheres to contain cancer therapeutics that melt at certain temperatures and have the potential to improve drug delivery.
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.