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In this Informatics In-Depth Focus: Informatics in 2025, Methods for…
In this Informatics In-Depth Focus: Informatics in 2025, Methods for the detection of drug-drug interactions in text & Computational approaches to mutagenicity assessments of impurities: in silico methods...
Historically, the regulation and control of medicinal products has relied…
Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the…
Maintaining the security of the supply chain for drug products…
Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines...
In this free-to-view LC-MS in-depth focus, we delve into the…
In this free-to-view LC-MS in-depth focus, we delve into the world of glycans, and how their natural complexity necessitates sophisticated sequencing techniques, while another article aims to demonstrate the versatility of LC-MS and the ease with which it can be combined with a variety of MS systems, focusing particularly on…
Increasing research and development costs, low productivity, reduced product life…
20 April 2015 | By Dave Elder, GlaxoSmithKline and JPAG
Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations.
The World Health Organisation (WHO) in 2010 described counterfeit medicines…
The World Health Organisation (WHO) in 2010 described counterfeit medicines as those which are “Deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active…
Cocrystals can help to address the manufacturability (flow, compaction, processability)…
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
Crystallography is the science underpinning crystallisation, as well as a…
Crystallography is the science underpinning crystallisation, as well as a basic understanding of atomic arrangement within solids and their resulting structures. The United Nations announced that 2014 would be the International Year of Crystallography (IYCr2014). IYCr2014 commemorates the 100th anniversary of X-ray diffraction according to Bragg’s Law (celebrated by the…
Analytical method specificity is assessed using ICH (International Conference on…
Analytical method specificity is assessed using ICH (International Conference on Harmonisation) Q2 (2005). Although, certain methods are not specific enough for their intended purposes, they may have other advantages. Both titrimetric and UV (Ultra-violet spectroscopy) assays are non-specific, but have superior precision (ca. 0.1-0.5% RSD (Residual Standard Deviation)) compared with…
An effective quality risk management (QRM) process ensures proactive identification…
An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…
An effective quality risk management (QRM) process provides a key…
An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the…
Whereas the existing ICH quality documents covering impurities in new…
Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic…
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs)…
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
Historically, control over metal impurities has been achieved via pharmacopoeial…
22 October 2013 | By David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca
Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) .
The International Conference on Harmonisation (ICH) guideline for the Validation…
The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…
