Remove Manufacturing Remove Pharmacology Remove Safety
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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 98
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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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Top-10 ways for Pharma to leverage AI according to…AI

Impetus Digital

Manufacturing Optimization While the manufacturing industry lags behind others in terms of AI uptake, there is no shortage of potential ways to leverage this technology. It also has the potential to reduce the high carbon footprint associated with manufacturing.

Pharma 89
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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.

Safety 98
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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 40
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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