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ICH Q6B for Analytics

PharmTech

A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs.

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Trade Policy Shifts: Compliance and Cost Strategies for Pharma

PharmTech

Waite further emphasizes the need for pharmaceutical companies to quickly build internal capabilities in customs compliance, including tariff classification, country of origin documentation, and accurate customs valuation. So we'll be looking for that and companies should be looking at that. Subscribe Now!

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CDC Report Finds No Connection Between Thimerosal and Autism

Drug Topics

In a new CDC report, investigators found that there was no connection between thimerosal in vaccines and autism or other neurodevelopmental conditions. The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines.

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The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

PharmTech

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Finalize documentation with full traceability and ensure preparations are quarantined until verified.

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Such logistics requires specialists in cold chain logistics, who need to maintain a full chain of custody and ensure traceability.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? To learn more about the solutions provided by Paradigm Health, download the document below. To serve both science and patients, the industry must embrace transformation before inefficiency puts progress out of reach. Sign up for our daily news round-up!