Applying Model Reduction to Lessen the Complexity of Quantitative Systems Pharmacology Models

One of the greatest challenges in drug development is the high attrition rate obtained in Phase 2 clinical trials, resulting in significantly elevated R&D costs and time. In fact, approximately 80% of new drugs that move into Phase 2—the phase when a new drug is first tested in humans—fail to demonstrate safety and efficacy.

Spotlight

Apotex Inc.

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. Founded in 1974, Apotex has steadily grown to employ over 10,000 people around the world, focused on research, development, manufacturing and distribution. Learn more at www.Apotex.com.

OTHER WHITEPAPERS
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Understanding Net Pharmaceutical Expenditure Dynamics in Europe

whitePaper | April 12, 2022

The level of pharmaceutical expenditure is closely watched and often commented upon, but the composition of that expenditure and its dynamics are not as well understood.

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Best practices in viral vector analytical characterization

whitePaper | December 13, 2022

Viral vectors are a critical part of the advanced therapies supply chain as they are used to introduce the gene of interest, whether that’s into a cell intended for therapeutic gene transfer or for direct viral-mediated gene transfer into the patient.

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Understanding the true cost of transparency reporting

whitePaper | December 14, 2022

When the regulatory hammer came down on pharmaceutical and life sciences (PLS) companies in the 2010s, it introduced new complexities for these businesses.

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Adapting to Pharma’s Next Normal

whitePaper | October 4, 2022

Let’s just say what we’re all thinking: 2020 was rough. It threw every element of our lives into disarray. We suddenly had to become experts at navigating a new way of working, schooling and socialising. It was disruptive and it was challenging, but it was also transformative

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Artificial Intelligence in Drug Manufacturing

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

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Potential measures to facilitate the productions of activepharmaceutical ingredients (APIs)

whitePaper | March 27, 2023

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply.

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Spotlight

Apotex Inc.

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. Founded in 1974, Apotex has steadily grown to employ over 10,000 people around the world, focused on research, development, manufacturing and distribution. Learn more at www.Apotex.com.

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