Articles
Start “Early” in Healthy for timely results for your dosage form
Early phase bioequivalence studies are/can be conducted on all USFDA Orange book approved list of dosage forms based on submission requirements by pharmaceutical companies This has been a market trend for more than 2 decades.
USFDA Orange book lists nearly...
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Managing Risks With Potent Pharmaceutical Products
As a noticeable shift occurs in the pharmaceutical industry from blockbuster drugs to smaller patient populations, there is an increased focus on targeted therapies in specialized areas, such as oncology, where potent compounds serve a key role in patient...
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Integrating biological safety cabinets into the cGMP environment to support aseptic processing
Pharmaceutical manufacturers have a duty to deliver consistently safe and effective medicines, and a fundamental part of this is ensuring products do not contain harmful biological contaminants. One approach that is widely used to guarantee drugs are free from...
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Redefining outsourcing: How the CDMO sector is reshaping its business
An ageing population, patent expirations, growth of disease prevalence, and expensive breakthrough therapies are driving demand for the development of many new pharmaceutical products. These growing pressures mean that pharmaceutical developers are faced with rising R&D costs and the...
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Drug Substances: Navigating Regulatory Requirements
With a central focus on human safety, high quality standards for drug products are upheld worldwide through various drug agencies. In order to ensure that drug products intended for human use fulfil the safety needs of patients, regulatory approval...
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Cold Chain Logistics: Powering Asia’s Biopharma Boom
As Asia’s healthcare systems mature, demand for the latest bio-pharmaceutical medicines is soaring. Most of these medicines are highly sensitive to temperature, meaning reliable cold chain services are crucial for effectively deploying biopharma across the region.
And the need for...
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New furnace for the innovative and sustainable production of clear-glass containers for solid and liquid drugs
Gerresheimer in Essen produces many millions of glass containers for the pharmaceutical industry every year. The long-established company has recently completed the routine renovation of its clear-glass furnace. Despite being more powerful, its improved technology means it uses less...
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