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

European Pharmaceutical Review

They detail the medication’s intended use, proper administration, potential side effects and precautions. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. References European Commission, (26 April 2023). Article 63 EMA (29 January 2020).

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4

Safety 113
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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs). S54 – S61 (2001). Grass and P.