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EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

PharmTech

SHOW MORE EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies. 2015 35(9):971-5. Techniques like organ-on-a-chip and cell transformation assays provide cost-effective, human-relevant models for pharmacokinetics and toxicity studies. NC 3Rs Workshop. J Appl Toxicol.

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OSD contract manufacturing market valued at $54.7 billion by 2030

European Pharmaceutical Review

A market report has projected that the global oral solid dosage (OSD) contract manufacturing market is expected to be worth $54.7 Slow-release formulations were a popular choice for manufacturers, as these varieties reduce the traditional dosage frequency for patients, who only need to take these medications say, once a week.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

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Are microtaggants the key to making medicines smarter?

pharmaphorum

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. It is estimated that the incidence of counterfeiting, illegal diversion and theft in the US increased by almost 70% between 2015 and 2019 driven mainly by a rise in internet sales. About the author .

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ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

Because the use of CM is expected to continue to grow beyond the current most common implementation for small molecule drug product, the focus on the guidance has been on general concepts that can be applied to any technology, dosage form, or molecule type.

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Patents: a necessary evil?

European Pharmaceutical Review

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.

FDA
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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. End-to-end continuous processes flow from starting materials to finished dosage forms.

FDA