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Bitesize Regulatory News 25 Apr 2022
International The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers for testing medicines post approval. According to the feedback from ICH the purpose…
Continue readingBitesize Regulatory News 25 Jan 2022
Europe EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According to the paper it will adapt some of the methods used in COVID…
Continue readingAssessment of Clinical Response
According to statistics back in 2012 there were approximately 981 drugs in development for cancer and this statistic is probably higher now. Some of the main challenges are how to…
Continue readingPharmacokinetics and Pharmacodynamics of Anticancer Drugs
In order to identify the correct dose of any therapeutic agent there are 2 pharmacological phases: Pharmacokinetic phase in which the dose, dosage form, frequency, and route of administration are…
Continue readingHow Do We Know if Drugs Are Carcinogenic?
We often see in the news headlines information of some drug being potentially carcinogenic or contaminated with substance that is potentially carcinogenic. But what that means and how do we…
Continue readingIs It Possible to Have an Anti – Cancer Therapeutic Vaccine?
There are many observations in melanoma lesions where the immune system is able to act against the tumours and usually this is a sign of a good prognosis. However, over…
Continue readingThe Role of MicroRNAs in Human Diseases
It is very common that microRNAs are overexpressed or inactivated in human diseases. The best approach in such cases is to either target the overexpressed microRNA to inactivate it or…
Continue readingCould Response – Based Dose Be the Future of Patient Care?
FDA report showed that most drugs are effective in only 25-62% of the patients. That probably make you wonder why they are approved and prescribed to patients? The answer to…
Continue readingAdopting Orphan Drugs in Different Therapeutic Areas
What happens if a newly developed drug fails in the tested indication? Very often such drugs are abandoned if the developers think they will not be able to be used…
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