Drug development is a highly regulated industry. Regulatory agencies are charged with protecting public safety as their first priority, thus they develop guidance documents to ensure the public that future pharmaceutical agents are safe. As regulators learn from experiences with many candidate drug molecules, they develop guidance documents to help other pharmaceutical companies develop safe medications. These guidance documents are often very comprehensive and include recommendations and rationale for the scientific topic. These documents that used to be 5 to 10 pages have ballooned to over 70 pages in some instances. The increase in document length creates a challenge for those working in the pharmaceutical industry because a large amount of time needs to be invested in reading the documents. In addition, the larger documents can be confusing and too comprehensive for rapid implementation.
My objective has been to educate and teach the pharmacokinetics industry using simple explanations. To that end, I have prepared regulatory guidance summaries for select regulatory guidance documents in the clinical pharmacology area. You can find these summary document, available for purchase on my website under Services > Regulatory Guidance Summaries. I will continue to add new guidance summaries over the next few months. In addition, I will update the summaries as guidance documents are updated or revised.
Each guidance summary contains the following:
- Executive summary (<1 page)
- High-level overview of each section of the guidance
- Bullet-point recommendations for each guidance recommendation
- Clear description of what is required and what is not required
- Total length of less than 10 pages
The guidance summaries are clearly written and concise. Each summary also includes the associated regulatory document for reference if further details are required. Purchases are handled securely by PayPal, and you will be able to download your document immediately. So, if you need to review a regulatory guidance, come get the guidance summary first and be an expert on the topic after a quick review of my summary.
You can download the regulatory guidance summaries here.