whitepaper
Whitepaper: Solubility: Importance, measurements and applications
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
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Formulation
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Learning the unwritten rules and dynamics of power
As part of EPR’s Women in Pharma series, Nawal Ouzren, CEO of Sensorion, talks to Science Editor Dr Zara Kassam about the diversity in drug development, creating a new growth mindset and elevating conversations beyond obvious beliefs...
news
Computer programme that could bypass patents to produce synthetic drugs
Software that can bypass current intellectual property and design medication with the same function as top drugs could help pharma companies...
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The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
news
Almac Group extends personalised cancer vaccine production facilities
The Almac Group, a CDMO serving the pharmaceutical and biotech sectors globally, is expanding its Edinburgh Technopole facility to allow scale-up of its personalised cancer vaccine activities...
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The future of precision medicine
As part of EPR’s Women in Pharma series, Ruth March, VP and Head of Precision Medicine and Genomics at AstraZeneca, talks to Science Editor Dr Zara Kassam about decreasing the clinical risk associated with solid tumour biopsy, balancing a scientific career with family life and taking advantage of company initiatives…
news
Inhaled dry powder formulation of treprostinil works well in PAH patients
A formulation of treprostinil as an inhaled dry powder has proven to be safe and effective, as reported in the safety analysis of a Phase III trial...
news
Developing the production of the radioisotope Tc-99m within the US
A team of university researchers have collaborated together to develop a method to produce the radioisotope Tc-99m in the US to prevent having to import it...
news
Diversifying drug development with a metal catalyst
Researchers have outlined a method of formulating drug-like aliphatic and aromatic carbon-hydrogen scaffolds into drugs using a metal catalyst...
news
Deloitte finds Pharma returns on R&D reach new low
Deloitte has found a sharp decline in the returns on investment from top pharmaceutical companies, with returns at almost half of what they were in 2010...
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Elemental impurities testing and specification limits – ICH Q3D
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
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Real-time PCR detection of S. aureus in pharmaceutical products
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
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Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
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Formulation, Development & Delivery In-Depth Focus 2018
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
