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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

FDA 52
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Fluconazole interactions to avoid

The Checkup by Singlecare

In that case, close observation is necessary for signs of withdrawal upon discontinuing fluconazole, and there might be a need to adjust the fentanyl dosage. Breastfeeding women prescribed fluconazole should openly communicate the risks and benefits, or possible alternatives, with their medical provider.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy.

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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. Pharmaceutical Engineering 42, no.

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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. Pharmaceutical Engineering 42, no.

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What is Content Mapping and How Does It Help Develop a Content Strategy in Pharma?

Viseven

Content mapping definition is the process of planning, organizing, and delivering content that aligns with the target audience’s needs at every stage of their journey. At the same time, healthcare providers may require more scientific info like clinical data, prescribing information, and dosage guidelines.

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Solutions to Increase Low Libido in Those with Hashimoto’s

The Thyroid Pharmacist

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. Well, mood can definitely be a root cause for low libido. 24] If the issue is brought up, today’s conventional approach is definitely lacking. The potential benefit?

Dosage 91