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Staff at NICE have co-authored a paper which suggests that new, histology-independent cancer treatments require more clinical evidence before approval recommendation by the institution.
Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
Researchers have proven their methodology for drug benefit evaluation to be effective as a decision support tool in a study with several European drug evaluation bodies.
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)
THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.
WITH THE RISE of metabolites/molecules production using complete living cells or their components (bacteria, enzymes, chloroplasts, etc), which is also termed bioprocessing, it has become increasingly important to control the different production steps and analyse the different biological materials.
Microparticles can be found everywhere, from pigments in paint and titanium dioxide in sunscreen to microplastics in water.
Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.