Guidebook for Drug Regulatory Submissions
Sandy Weinberg, Wiley, 2009. 379 pages

f you thought writing a research grant was tedious, try writing an IND or an NDA sometime. If you're one those lucky bastards who doesn't know what an NDA is, you'd probably think the guidance here about how to deal with the FDA would be unimaginably boring, and you'd be right. Much of the book consists of big slabs of unreadable 21 CFR regs and parts of FDA "Guidance" documents, cut and pasted from government web pages. But some parts of the book were actually written by the author, and these contain well-written insights and useful advice on what to do and, just as importantly, what not to do.

One recent change is that the FDA has moved closer to all-electronic submission. Since these forms can be up to 100 GB in size, the FDA is moving slower than the NIH, which stopped people from sending packages to them (even those not making any ticking sound) shortly after 9/11.

Billions of dollars are spent each year filling out these forms. So it's critical for your company's bottom line as well as its reputation to develop in-house expertise in dealing with the FDA and its European equivalent, the EMA. This book is mostly US-centric, but other markets are described in a brief chapter. The biggest section is on NDAs. Physician-initiated INDs are not covered.

Although there's a perception that the FDA is in bed with industry, nothing could be farther from the truth. Their primary concern is following the regs. Using the wrong type of binder, for example, can cause the FDA to delay approval of a new lifesaving drug by months or years. Weinberg says the preferential treatment given to academics by the FDA has been a significant factor in killing off biomedical research programs in industry. In Europe, unlike the USA, the patent clock is frozen during the review process, which means American pharmaceutical companies face much tougher challenges staying afloat.

If you, like someone I know very well, find yourself working for a company whose management thinks they know everything there is to know about the process of getting a drug approved, yet somehow manages to fail at it repeatedly, this book can help you find a new job when they turn their skill and intelligence to something they have more experience in, like doing Chapter 11s. That only requires a B9F, which is a lot easier to fill out. Heck, I could even send you one.

oct 20, 2012

Design and Analysis of Clinical Trials: Concepts and Methodologies, 3e
S.C. Chow and J.P. Liu, Wiley, 2014, 870 pages

his one is also a little verbose and repetitive, but that's because the authors give so many detailed examples of clinical trials and what was good and bad about their design. This book isn't for a casual reader. It's for somebody who's involved in a clinical trial and needs lots of hand-holding. Millions of dollars and hundreds of lives are at stake, so you can't afford to make a mistake. There are many huge tables and lots of statistical equations. It's up to date and accurate as far as design of trials goes, but the chapters on biostatistics are way too abstract for the intended audience. There's also a good overview of the principles of traditional Chinese medicine.

mar 07, 2016

Principles and Practice of Clinical Trial Medicine
R. Chin and B. Lee, Academic Press, 2008, 547 pages

lthough there's lots of useful information here, the authors try to cover every topic for every type of reader. They try to cover PK/PD, statistics, FDA regs, study design, and data analysis. As a result, this book (especially the first half) is inexcusably verbose. Concepts that could be expressed in a sentence are stretched into multiple paragraphs, illustrated with overly simple, concrete examples about basketball players, student grades, hair stylists, and cooking turkeys. After 150 pages of this, I found myself saying, "All right, we get it, we get it!" The last 143 pages consist of FDA documents and forms, most of which are of marginal interest.

nov 03, 2012