GMP – Good Manufacturing Practice makes perfect

Wednesday, October 14th, 2009

beakersManufacturing drugs for human use is a complicated process frequently involving compounds and materials that, if used incorrectly, can be hazardous to people’s health. Highly regulated nations (such as the US, EU, Australia and Canada) have long realised the necessity that they develop strict guidelines governing these processes to protect patients and ensure product safety, quality and efficacy. Poor quality drugs, manufacturing processes or conditions can have extreme and dire consequences for patients. In countries that enforce Good Manufacturing Practice (GMP) the penalties for non-adherence reflect its importance and can include forcing worldwide product recalls, seizure of property, large fines, even imprisonment.

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A brief history of afamelanotide

Friday, October 9th, 2009

Photoart_0117The research that underpins afamelanotide began over 20 years ago in the US. At that time the dramatic increase in incidence of skin cancer and its impacts were beginning to be discovered and new solutions sought. The National Cancer Institute (NCI) sponsored researchers to explore applications for various peptides as part of its melanoma prevention strategy.

This study led them to investigate peptides that acted on melanocyte receptors. The rationale behind this being that increased melanin leads to more efficient photoprotection, as melanin is a highly successful and naturally occurring UV quencher and filter. By consistently increasing melanin in the skin, skin damage from light and UV radiation can be lessened.

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Killing cancer in the UK

Thursday, October 8th, 2009

unitedkingdomA new initiative has just launched in the UK with the goal of increasing awareness and support for the more widespread use of photodynamic therapy (PDT). Compared to surgery and chemotherapy, PDT is a relatively simple, quick and effective treatment for certain types of cancer that we have covered previously on this blog.

Killingcancer.co.uk is a fundraising initiative aiming to create both a groundswell of interest and a pool of funds to support the development and access to PDT in the UK, to make it more readily available through the National Health Service (NHS). Through a mix of celebrity endorsements and patient stories they build an informative and compelling case for their cause.

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New media communication and the effects on pharmaceuticals

Friday, September 4th, 2009

Photoart_0117The millisecond transfer of data packs has changed medicine for good. When it comes to gaining online information about our health the pros outweigh the cons. We are seeing in modern medicine that patients are well prepared when seeking health consultation. Sites such as eMedicine, YahooHealth and the Dermdoctor contribute to our deeper understanding of medicine. The endless flow of free information will certainly have its effect on drug development too, but the lack of direct contact between the pharmaceutical company and its end-customers traditionally forces drug developers to primarily focus on the prescriptive behaviour and needs of physicians.

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The drug development process – Part 3

Tuesday, September 1st, 2009

Test Tubes 1This is a continuation of the post “The drug development process – Part 1” and “The drug development process – Part 2″

The 3 Phases of clinical trials are strictly monitored and controlled by different regulatory bodies such as the FDA (US), the TGA (Australia), the EMEA (EU) and SwissMedic.

All trials must undergo the same rigorous process as outlined in our previous post, but are quite distinctly different and influenced by a number of other factors.

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Light, life’s invisible paradox

Friday, August 28th, 2009

Photoart_0117During more than a decade of clinical research on Clinuvel’s proprietary drug afamelanotide, our teams have specialised in, and focused on, the study and importance of light absorption for our health and well-being.

However, light is regarded as an ‘optical paradox’: too little may result in vitamin D deficiency or seasonal affective disorder (SAD), while too much may result in skin cancer. In seeking answers from related fields, our in-house scientists often remark that human biology is unfortunate to lack green chlorophyll with its ability to efficiently process light into nutrition.

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