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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

1 These substances “are pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained. In this Q&A, Dr Hotha offered expertise on the requirements and challenges of handling HPAPIs during manufacture.

Safety 92
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Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. Specifically, it described how ERP systems clarify every aspect of operations in a business for drug serialisation compliance.

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Leading API biologics (protein and peptide) companies in contract marketing

Pharmaceutical Technology

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development.

Leads 52
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The future of medical cannabis development in Europe

European Pharmaceutical Review

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry.

Medical 86
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Regenerative potential: cell?based therapies for heart failure

European Pharmaceutical Review

Pharmacological therapies mainly address symptoms and unfortunately a significant number of patients do not respond adequately, progressing to congestive heart failure and eventually needing a heart transplant. Despite these trials varying in design, they confirmed the feasibility and safety of the procedure. Frontiers in Pharmacology.

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Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

FDA 105