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ISPE’s Regulatory Commenting Process

ISPE

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

This suspicion was confirmed in a 2004 analysis by researchers from Oxford. They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

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Remote Acceptance Testing of Automation Projects

ISPE

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. Audio-visual communication. Text communication. Technology and communications requirements. Technology and communication requirements. Table 3: Codes. Advantages.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Air Speed Qualification: At Working Position or Working Level?

ISPE

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 October 2004. But it is likely that interpretations in practice refer to footnote 5 from FDA Aseptic Guidance 2004: 7 “A velocity of 0.45 You may unsubscribe from these ISPE communications at any time.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

September 2004. Nature Communications 12, no. September 2004. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Journal of Pharmaceutical Sciences 111, no. 3 (2022):593–607. 3 (2020):e2970.

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How Thyroid Disease Affects Men

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. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! Published 2004 Aug 18.