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ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD

ISPE

The team, composed of end user pharmaceutical companies, equipment vendors, and academics, set out to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest enhancements to current equipment. Meet Heather Patterson, Human Resources Manager.

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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

By removing the need for manual handling and reducing the risk of contamination, pharmaceutical manufacturers can produce products that meet the highest standards of quality. Automated systems offer a range of options for pharmaceutical companies. This also results in significant cost savings and increased efficiency.

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12 Medications With Off-Label Uses

BuzzRx

Off-label drugs are approved drugs prescribed for an indication, a patient population, a dose, or a dosage form that has not been approved through the usual FDA approval process. Given in a dosage form that is not FDA-approved. We will also list some common examples of off-label drug use. What is off-label drug use?

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. With this added knowledge, researchers can design more efficient and effective clinical trials while identifying the most suitable patient populations, treatment regimens and dosages.

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Pharmaceutical Procurement Strategies Overview

Viseven

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

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Ready, steady, scale: How to mitigate risks in process scale-up

Pharmaceutical Technology

With the ever-rising costs of bringing a drug to market, pharmaceutical companies are increasingly looking at how they can improve the efficiency of their entire product development and drug commercialisation process. This important stage of the drug’s lifecycle can be very time-consuming for pharmaceutical companies.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. End-to-end continuous processes flow from starting materials to finished dosage forms.

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