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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation.” Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. Lakerveld, B.

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CMC Requirements for New Drug Registration in Latin America

ISPE

The information required in these declarations include product information (name, strength, dosage form), manufacturer, packager and license holder, and drug product manufacturing site name and country. In Chile, it is required to include specific tests in the local drug product specification, depending on the dosage form.

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma. Credit: Saiful52 / Shutterstock.

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Do stimulants such as Adderall work for depression?

The Checkup by Singlecare

Food and Drug Administration (FDA) as a treatment for narcolepsy. SSRIs are the most commonly prescribed type of antidepressant —and they are approved by the FDA for this purpose. It’s also approved by the U.S. When using Adderall off-label for depression, there are many things prescribers consider. Here’s what you need to know.