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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

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The benefits of mass spectrometry for expediting biologics to patients

European Pharmaceutical Review

Conversely, poor analytical characterisation will likely lead to questions from regulators and, without sufficient product and process knowledge, an IND or BLA that is eventually deemed incomplete. Incorrect DNA sequences can also lead to high levels of SVs. While SVs are typically present at less than 0.1

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”. The regulatory landscape around COAs is fast evolving.

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Inlet air conveyor optimisation in a continuous tablet coater

European Pharmaceutical Review

The uniformity of the film layer is of utmost importance: it directly relates to the safety and efficacy 1 of the pharmaceutical tablets. Lower velocities and uniform distribution of inlet airflow leads to less spray losses, since the coating arm gets less dirty, and to a more uniform tablet bed temperature even with an elongated table bed.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”

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Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Legacy MEDSearch

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.