Strict Standards

4.2 Strict standards
Furthermore the research on finding new antibiotics is strictly regulated under standards, licenses and regulations, which make the process of finding new antibiotics very hard and non-lucrative for companies [9]. Most antibiotic trials are based upon an equivalent already existing antibiotic. These trials underlay very strict standards, such as that the antibiotic which gets tested must achieve equivalent or similar efficiency as the older version. The amount to which the efficacy of the new agent can differ from the comparator and still be considered sufficiently similar to be equivalent should not exceed 15%. However due to concerns about possible “downward” drift in efficacy over time, some regulatory authorities have proposed a reduction to 10%. Therefore it is much harder to achieve and limits the research on finding new antibiotics as approximately double the amount of patient participating in a trail are needed which increases the costs of the trail drastically [9]. Furthermore these changes in strict standards and regulations increased the time of the trails which increased the risk of emerging antibiotic resistance. Additionally, varying licensure regulations exist in the United States, the United Kingdom, Europe, Australia and South
5. Opportunities of finding new antibiotics
Although the amount of new antibiotics decreased dramatically since the golden era of antibiotics and although a lot of limitations and barriers exists which hinder the forward movement of finding new antibiotics, which are needed as urgent as possible due to the rapidly spreading antibiotic resistance to the current antibiotics, many opportunities of finding new antibiotics exist and are