--- product_id: 28007108 title: "Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines" price: "R3682" currency: ZAR in_stock: true reviews_count: 9 url: https://www.desertcart.co.za/products/28007108-clinical-trials-study-design-endpoints-and-biomarkers-drug-safety-fda store_origin: ZA region: South Africa --- # Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines **Price:** R3682 **Availability:** ✅ In Stock ## Quick Answers - **What is this?** Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines - **How much does it cost?** R3682 with free shipping - **Is it available?** Yes, in stock and ready to ship - **Where can I buy it?** [www.desertcart.co.za](https://www.desertcart.co.za/products/28007108-clinical-trials-study-design-endpoints-and-biomarkers-drug-safety-fda) ## Best For - Customers looking for quality international products ## Why This Product - Free international shipping included - Worldwide delivery with tracking - 15-day hassle-free returns ## Description Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers Review: Great Reference for Those Working in Industry - I would strongly recommend this book for those beginning a career in the pharmaceutical industry or for those already working in industry for use as a reference. It is especially useful in the oncology therapeutic area and for its explanations of frequently-used statistical analyses. It is thorough, broad in scope, and well-referenced. After more than 20 years of working in industry, I find it relevant and extremely useful. It would be a wonderful text book for a graduate-level introduction to clinical research in industry. I'm very glad to have invested in this addition to my reference library! Review: DRY READ - This has good information, but its so hard to get through because the reading is so dry! ## Technical Specifications | Specification | Value | |---------------|-------| | Best Sellers Rank | #1,051,601 in Books ( See Top 100 in Books ) #58 in Clinical Pharmacology #325 in Pathology Clinical Chemistry (Books) #405 in Medical Research (Books) | | Customer Reviews | 4.2 out of 5 stars 30 Reviews | ## Images ![Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines - Image 1](https://m.media-amazon.com/images/I/71Og85DfitL.jpg) ## Customer Reviews ### ⭐⭐⭐⭐⭐ Great Reference for Those Working in Industry *by S***R on December 9, 2016* I would strongly recommend this book for those beginning a career in the pharmaceutical industry or for those already working in industry for use as a reference. It is especially useful in the oncology therapeutic area and for its explanations of frequently-used statistical analyses. It is thorough, broad in scope, and well-referenced. After more than 20 years of working in industry, I find it relevant and extremely useful. It would be a wonderful text book for a graduate-level introduction to clinical research in industry. I'm very glad to have invested in this addition to my reference library! ### ⭐⭐⭐⭐ DRY READ *by V***G on October 23, 2024* This has good information, but its so hard to get through because the reading is so dry! ### ⭐⭐⭐⭐⭐ Five Stars *by A***R on August 9, 2016* Clear, well-structured,up-to-date ## Frequently Bought Together - Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines - Fundamentals of Clinical Trials - Introduction to Statistical Methods for Clinical Trials (Chapman & Hall/CRC Texts in Statistical Science) --- ## Why Shop on Desertcart? - 🛒 **Trusted by 1.3+ Million Shoppers** — Serving international shoppers since 2016 - 🌍 **Shop Globally** — Access 737+ million products across 21 categories - 💰 **No Hidden Fees** — All customs, duties, and taxes included in the price - 🔄 **15-Day Free Returns** — Hassle-free returns (30 days for PRO members) - 🔒 **Secure Payments** — Trusted payment options with buyer protection - ⭐ **TrustPilot Rated 4.5/5** — Based on 8,000+ happy customer reviews **Shop now:** [https://www.desertcart.co.za/products/28007108-clinical-trials-study-design-endpoints-and-biomarkers-drug-safety-fda](https://www.desertcart.co.za/products/28007108-clinical-trials-study-design-endpoints-and-biomarkers-drug-safety-fda) --- *Product available on Desertcart South Africa* *Store origin: ZA* *Last updated: 2026-09-13*