Utilising naturally occurring endotoxins in recovery studies
The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
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The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s novel approval means that certain patients with HIV have more options for treatment.
European Pharmaceutical Review's latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options…
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
The versatility of liquid chromatography is propelling demand for high-quality chromatography reagents, the report stated.
Formulation experts from Polytechnic of Turin, Italy, discuss the impact of freeze-drying on the integrity and stability of pharmaceuticals and how mathematical modelling can improve understanding of the freezing process.
Following the appointment, Thomas Hudson, AbbVie’s current Senior Vice President, Chief Scientific Officer, Global Research, will retire.
The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
The Association of the British Pharmaceutical Industry (ABPI) and Drug Research Safety Unit (DRSU) assert the importance of partnership and collaboration to support the pharmaceutical industry under the new UK government.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.