3 The Pii Formula, Early-Stage Drug Development, October 23

3 The Pii Formula, Early-Stage Drug Development, October 23

Pii Formula

Welcome to the October edition of The Formula. This issue highlights the importance of early-stage drug development and some of the strategies to deploy. Find out how partnering with a skilled contract development and manufacturing organization (CDMO) will help gather appropriate data and overcome common obstacles to reach a quick go/no-go decision. As always, we look forward to receiving your questions and feedback at pdupont@pharm-int.com.

Main Feature: The Importance of Early-Stage Development

Both large and small pharma and biopharma organizations can mitigate risks and costs by partnering with a CDMO that specializes in early-stage development processes, including pre-formulation studies and drug product evaluations.

Learn how to quickly get to a go/no-go decision, scale up formulations from lab to IND, and accelerate timelines in the post-IND stage.

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CDMO Insights: How to Clear 5 Early-Stage Development Hurdles

Just one drug per 1,000 that enter pre-clinical trials will advance to human clinical trials. And this is not because the other 999 drugs are unsuitable for therapeutic use, but rather because of mistakes made in the early stages of development.

Find Out how partnering with a CDMO to guide you past these obstacles may improve the odds of getting your drug to market.

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Application Feature: Applying Quality by Design to Pharmaceutical Research and Development

QbD asserts that quality be designed into a drug. While often discussed in the context of process and development, this article focuses on how QbD should begin in the early stages of drug development to drive better results throughout the drug development process.

QandA

Q&A: Do you have a question for the Pii formulation team?

Submit your questions to us at pdupont@pharm-int.com and see them answered in a future edition of The Formula.

Interested in more on Early-Stage Development? Check out our latest Bioavailability eBook

or contact Paul if you have questions about your oral products: pdupont@pharm-int.com.

Cindy H. Dubin, editor of The Formula

Cindy H. Dubin is an award-winning journalist who has been reporting on the bio/pharmaceutical industry for more than 20 years. Her published work includes formulation development, manufacturing, drug delivery, QA/QC, cell and gene therapy, and more.

cindy
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