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Combining crotoxin with silica enables safe administration in animals
The toxicity of crotoxin has been significantly reduced by combining it with nanostructured SBA-15 silica, used in vaccine formulations.
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Toxicology
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FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
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MHRA suspends license for Picato over concerns of skin malignancy risk
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
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EMA releases findings from pharmacovigilance report
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
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FDA releases statement on ranitidine testing results
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
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MHRA announces recall of Zantac products made by GSK
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
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FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
whitepaper
Journal article: Validation of Milliflex quantum for bioburden testing of pharmaceutical products
Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms).
whitepaper
Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
whitepaper
Article: Inorganic elemental impurity mixes according to ICH Q3D guidelines
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
whitepaper
Article: Elemental impurities: certified reference materials for ICH Q3D, USP<232> & <2232> and Ph.Eur. 5.20
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
article
Wickham Laboratories Ltd: backed by five decades of global experience
Wickham Laboratories Ltd, backed by five decades of global experience in GMP/GLP-regulated laboratory services, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
news
Carbon nanotubes may pose cancer risk similar to asbestos
A study has provided strong evidence that certain carbon nanotubes used in manufacturing could pose the same cancer risk as asbestos...
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Combined therapies increase side effects for patients with advanced breast cancer
Patients with advanced breast cancer who are treated with a combination of drugs are at increased risk of suffering adverse side effects...
