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This year marks the 10th anniversary of the introduction of the International Conference on Harmonisation (ICH) guidance on stability testing of new drug substances and products (ICH Q1A(R2)) and the ancillary guidance on storage conditions (ICH Q1F). In 2003, the pharmaceutical industry thought that it had achieved its goal of…
18 April 2013 | By Radhakrishna S. Tirumalai
For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout…
18 April 2013 | By Michela A. Denti and Margherita Grasso, Laboratory of RNA Biology and Biotechnology, Centre for Integrative Biology, University of Trento, Mattia Barbareschi and Chiara Cantaloni, Unit of Surgical Pathology, Santa Chiara Hospital
In 1993, the laboratories of Victor Ambros and Gary Ruvkun, studying the larval development of the nematode Caenorhabditis elegans, found a small RNA molecule (22 nucleotides) which regulated the translation of the lin-14 gene in an unusual way1,2. They observed that the sequence of the tiny lin-4 RNA was complementary…
18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG
The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…
Erica Hirsch, Product Manager at Thermo Fisher Scientific looks at the next generation handheld Raman spectrometer the Thermo Scientific TruScan RM...
18 April 2013 | By Pedro R. Cutillas, MRC Clinical Sciences Centre, Imperial College London
Not all cancer patients, even those with the same tumour type, respond to therapy equally well. An understanding of this heterogeneity at the molecular level is crucial for further advances in the development of cancer therapies. Discerning the mechanisms of cancer heterogeneity will lead to a better selection of the…
18 April 2013 | By Pascal Furrer, Pharmacist
Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture…
Metrohm, a leading manufacturer of instruments for chemical analysis and FOSS, a leading supplier of dedicated analytical solutions to optimise quality and control, have entered into a strategic alliance strengthening the two companies’ leading positions in their respective key markets. In this strategic alliance, Metrohm will become the sole global…
In this Mass Spectrometry In-Depth Focus: Corticosteroids and mass spectrometry; latest applications using LC/MS; Multi-analyte LC-MS/MS assays for the quantification of endogenous compounds during the development of drugs and companion diagnostics...
In this Stem Cells In-Depth Focus: The promise held by induced pluripotent stem cells for research and regenerative medicine; Workshop preview – Cell based assays for screening; Cardiac stem cells; Stem Cells Roundtable...
