Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

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Pharmaceutical Representative Training

JUNE 22, 2024

The pharmaceutical industry is one of the most heavily regulated sectors due to the direct impact of its products on public health and safety. Several factors contribute to the stringent regulatory environment: Patient Safety: Ensuring that the pharmaceutical products are safe and effective is a crucial aspect.

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Impetus Digital

AUGUST 2, 2024

In 2020, McKinsey estimated that over the next 3–5 years, the average top-20 Big Pharma company could unlock over $300 million a year by adopting advanced RWE analytics across its value chain. To avoid compliance issues , it is essential to keep up with new regulatory changes, including updated reporting guidelines and safety requirements.

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Pharmaceutical Representative Training

JANUARY 30, 2025

3 Together, these processes determine the drugs concentration in the bloodstream and tissues over time, directly impacting its effectiveness and safety. A highly effective drug (PD) may pose safety concerns if it accumulates due to slow metabolism or excretion (PK). Rang & Dale’s Pharmacology. Published June 26, 2020.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile. While favourable safety has been reported up to the Phase II, the relevance of targeting the C-terminal portion of Abeta still needs to be confirmed.

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Legacy MEDSearch

AUGUST 25, 2022

The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020.

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pharmaphorum

DECEMBER 20, 2022

That’s impressive, as it has proved exceedingly difficult for pharmacological therapies to show an impact on fibrosis in prior studies. Similarly, a one-stage or greater improvement in liver fibrosis was seen in 24% and 26% of the resmetirom groups, respectively, versus 14% of patients taking placebo.

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