Vaccines are one of the few medical interventions which are regularly undertaken by healthy individuals. As a result, the bar for ensuring the safety of a vaccine is extremely high. It would be difficult to justify administering a preventative vaccine for a disease an individual might contract if that vaccine regularly causes serious side effects…
Vaccine development often only hits the headlines when there’s a breakthrough clinical trial or final approval. Behind every successful vaccine, however, is a lesser-known stage of research that quietly lays the groundwork: preclinical studies. Don’t be fooled: these early investigations are essential for answering crucial questions which underpin the future of the vaccine. Is the…
The earliest stages of the development of any vaccine involve laying out the roadmap for its design and testing. A vast network of interlinked paths from a new idea to a needle in a patient’s arm stretch ahead into the future, each with unique regulatory and ethical implications. Should the vaccine target a certain strain…
The control: a vital part of any scientific experiment. The only way to establish causality between the dependent and independent variables in an experiment is by comparison with a control. Controls are also important for establishing detection background: what does “nothing” look like on your sensor? Bioassays are no different: including control wells in your…
Validation of statistical software is required for use in regulatory work. Many auditors expect to see the traditional IQ, OQ, PQ approach applied to the base system (SAS, R, etc). This approach, however, was never mandated by the FDA – or anyone else – and was never really suited to software validation because it ignores…
One of the most important concepts in bioassay is that of replication. Test samples are regularly replicated 2 or 3 times. Multiple response measurements at each dose will, in general, result in a better estimate of the precision of our result. As with all biological experiments, however, there is often quite a lot of variability…
Choosing the right Parallel Line Analysis (PLA) software for your lab is not an easy task. Whilst there are several packages available, and most can perform an adequate standard job, at least for development, it can be a challenge to know what aspects to consider. This is an important consideration as choosing the right software…
At the recent BEBPA meeting, in response to the question: ‘If you have a zero dose control on your plate do you include it in your 4PL model?’ 78% responded either “no” or “don’t know” or “did not know I could”. Well you can! Just add them into the datapoints for the reference and/or the…
Accuracy and Precision are properties of an experiment which are often conflated — not least because they are often synonymous in everyday conversation. In science, however, they have separate, well-defined meanings. Of course, this also applies to bioassay, so we thought we’d take a look at the difference here. Accuracy is the ability of an…
Designing and running a clinical trial for a medical device is expensive, and to avoid wasting money, time and risking the validity of the trial, it is important to get the design right. To provide a little more insight, we thought we would discuss some recurring errors that Quantics has observed in trial synopses and…