Statistics for Bioequivalence
Quantics has years of experience applying our world-leading expertise to bioequivalence statistics.
Whether you’re planning your next study or approaching license application, Quantics is here to help. Our detailed approach to quality management – and deep understanding of the latest guidance – means we can provide relevant support at every stage along the road to regulatory approval.
First-class support for Bioequivalence studies
Quantics can provide statistical support for all stages of a bioequivalence study, including:
- Study Design
- SAP preparation
- Project management
- Document review
- Statistical programming
- Regulatory submission
Working to the latest guidance
Our team are experienced in working closely to a range of regulatory guidance for bioequivalence statistics, from the FDA to the EMA and beyond. We will help ensure your submission contains everything required for a smooth passage through to licensing. We have worked extensively to both Average Bioequivalence (ABE) and Population Bioequivalence (PBE) regulations, meaning we can provide support no matter the design of your study.
Quantics is the only GLP-licensed independent statistical consultancy. We work to stringent quality management standards, including regular audits for GMP and ISO9001.
Customised Service
Fast, reliable service customised to your needs
Solutions at any Stage
Support throughout the journey to regulatory approval and beyond
Peace-of-Mind
Detailed-orientated management providing high quality results
Experience
World-leading expertise and years of experience providing bioequivalence statistics
What is Bioequivalence?
The importance of bioequivalence (BE) arose in the 1980s as many of the first innovator therapeutics began to reach the end of their patent windows. This saw the rise of generics. By 2009, generic prescriptions made up 2/3 of those filled in the US, but represented just 13% of the costs. BE presents a vital methodology to ensure the safety and efficacy of these generics without requiring expensive clinical trials, reducing the cost of the therapeutic for the end user.
BE is vitally important for improving access to therapeutics by removing the need for expensive clinical trials. But how does it work? In short, the goal of a BE study is to show that the product under investigation behaves identically – or near enough – to a previously approved product when used as a therapeutic.
This is far faster and less expensive than a typical licensing process. For example, in the US – under the jurisdiction of the FDA – a novel therapeutic can apply for regulatory approval under a New Drug Application, or NDA. This can take several years or even decades from discovery to approval, including several rounds of clinical trials. By contrast, a generic drug can be approved under an Abbreviated New Drug Application, or ANDA, which cuts out the requirement for clinical trials in favour of a bioequivalence study.
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