The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
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Whitepaper: Establishing the proper alcohol/water proporation for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (Ethanol/water proportion) on the levels of Extractables.
Included in this in-depth focus are articles examining the importance of child-resistant medicinal packaging and analysing whether continuous processing is the future for pharma.
Biologics continue to be a major modality in the pharmaceutical pipeline. New and unique LC-MS tools will become available for use from discovery through QC.
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
The MHRA has issued two alerts, one for incorrect maximum daily dosage of Ibuprofen 400mg and a second for missing safety information about Oxylan Prolonged-release tablets.
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension USP due to concerns about failure to re-suspend resulting in under or overdosing.
Side effects revealed during post-marketing experience are not listed on Atrolak XL prolonged-release tablet patient information leaflets, announces the MHRA.
Research has found that technological innovation and legislation are to drive the growth of the global anti-counterfeit packaging market.
According to the MHRA, the finasteride 5mg tablets produced by Dr Reddy’s do not contain certain warnings and precautions in the patient information leaflets.
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
Pharmaceutical industry experts have highlighted the key trends for the coming year for drug delivery and packaging.
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.