I've worked in the pharmaceutical industry for a long time, focusing on clinical pharmacology and pharmacometrics. When I started, I was called a pharmacokineticist. Today, that term has largely vanished, replaced by pharmacometrician. My job, in a sentence, is to find the right dose of a new drug for patients. I am fortunate enough to manage a group of pharmacometricians at Astellas, a mid-sized Japanese pharmaceutical company. Collectively, we use mathematical and statistical models to explore the dose-concentration-response relationship and use that relationship to find the best dose for patients in the sense of maximizing the benefit-to-risk profile of the drug.
In my role, I interact with lots of people in many different departments, not just people in my department, but many more outside my department. Not just scientists but lots of non-scientists as well. Lawyers. Contract specialists. Administrative Assistants. Statisticians. Pharmaceutical scientists. Patient advocates. Medical Science Liaisons. Lots of people.
What I have found is that, while we all work together at a pharmaceutical company, not everyone understands what it takes to bring a drug to market. How does a drug get discovered? What studies are needed for a drug to be tested in humans? What studies are needed to get a drug reviewed by regulatory authorities and approved? What might happen after a drug is approved? And, how do you make sense of those gigantic one-page documents they give you when you get a new prescription with a font so small you need a magnifying glass?
I decided that what was needed were some training classes on the drug development process that everyone could understand, especially non-scientists. I worked with the training group at my company (shout out and thanks to Erin Neiman, Don Sandel, and John Fort on for their help) to develop what we called Drugs 101. It was six half-day lectures over a couple of months that began with the question, "What is a drug?" What's the difference between a brand-name drug and a generic? What is a biologic? A biosimilar? How does a supplement differ from a drug? Or a nutraceutical? Can foods be drugs? Can drugs be foods? And what's the deal with soap and chewing gum?
We then moved into how drugs work in the body and discussed pharmacokinetics and pharmacodynamics. Why do some drugs have to be taken one, two, or three times a day? And how did Maria Sharapova try to use pharmacokinetics to save her from suspension in the Australian Open?
In the later lectures, we discussed Drug Discovery and Drug Development, Precision medicine and pharmacogenomics, Food, Drug, and Beverage Interactions, AE, SAE, SUSAR, Say What?, and Special Populations.
Reviews from the class were also positive, and people kept saying I should turn it into a book. Then the pandemic hit. After a few months, I decided now was a good time to start writing, since we had no idea how long this lockdown would last, and I was restless. Now, six years later, I have finished writing it, after many late nights and weekends working on it. There was even a period of almost a year when I had to take a break from writing because I was burning out.
The book is called Drugs Explained. I originally named it How Drugs Work, but last year I found out there was another book with the same title. So, I changed it to Drugs Explained. I liked the sound of it. Short and punchy. I wasn't writing an academic book. I was writing a book for everyone, so I needed a catchy title.
The contents of the book are:
I was inspired by the format of Nature Reviews Drug Discovery. Review articles have these colored pop-up boxes with little side bits of information related to the topic, but maybe not directly. This book has lots and lots of side boxes with interesting (at least I think it's interesting) information related to the chapter or what is being discussed. The book is written for those with some knowledge of basic biology and chemistry, but most chapters can be read even if you don't know much about either. Chapters 4 and 5 are the most technical in the book, and could be skimmed over if need be.
As I was writing the book, over the years, things changed. Regulations changed. New drugs were approved. New developments about pharmaceutical companies and drugs were released, prompting me to go back, update, and revise it many times. It made me realize that this book could not last long as a stand-alone fixed-in-time document. It would be outdated in less than 10 years. It needed to be a living document. But how could I make it a living document? I couldn't just make changes and then update Amazon with a new version of the book. Or could I? I've published other books through traditional publishing houses, and I learned a long time ago that the only ones getting rich publishing the types of books I write are the publishers, not me. So I made a decision. I didn't need the few thousands of dollars in royalties that a book like this would generate, so I decided to make it available for free. And I did.
In February 2026, I made the book available on GitHub (https://github.com/peterbonate) and on my own website (www.peterbonate.com). It is free as a pdf, but if you want a hardcover copy, it is available on Amazon.
What I am really excited about is the book's living-document nature. I plan to add new chapters in the years ahead. I'd like to write chapters on veterinary drugs, on food law (Food and Drugs Explained?), and on the commercial aspects of selling and marketing drugs. But these are things I am not too familiar with and I need to do a lot of research first before I start writing. I also plan to keep the regulatory sections up to date and relevant. Each version of the book will have a change log showing where changes were made from the previous version.
This book is a great resource for mathematical oncology researchers because it explains how drugs are actually developed and approved. You'll gain practical insights into drug discovery, clinical trial design, and how drug development fits into a regulatory framework. The book connects the dots between scientific concepts and real-world applications, helping you understand how your quantitative models fit into the bigger picture of cancer drug development. It's written in an accessible, mostly non-technical, engaging way that makes the complex drug development process easy to grasp, whether you're focused on optimizing trials or predicting patient outcomes.
Many people think the hardest part of writing a book is the writing. I have never found that to be the case. You organize your material, plan what you want to say, carve out the time, and then focus and write. It's not hard. What is hard, though, is after you are done and you release the book to the public. What will people think? Will they think it's interesting? Will they find it boring? Or worse, will they not care? That's the hard part. The uncertainty. You want people to read your book. You want them to find it interesting. I hope I have done that. I hope I've written a book that people will say afterwards, "That was pretty good."
I look forward to hearing your comments. Don't hesitate to send me your thoughts at peter@peterbonate.com.
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