Extensively updated, this third edition provides a valuable guide to the tools and techniques used to perform Phase 1 site assessment. This book elucidates the systematic processes and methods used by leaders in the industry. It also emphasizes the development of an easy-to-follow investigative strategy for in-house assessment. After reviewing the history of the field, legal issues, and important terms, the book discusses physical setting, historic usage, property and area reconnaissance, building materials, and industrial activities associated with a property. It also gives interviewing tips, lists regulatory agencies, and considers unique situations such as wetlands and historical buildings.

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Newly updated for 2020 DoD SBIR Release! The purpose of this book is to guide you through the DoD SBIR program and make your proposal creation easier, compliant and increase your success probability. My intent is that you will effectively: •Understand the DoD SBIR program •Learn my method for getting solicitation’ topics tailored to the problem you solve •Create a compliant and standout proposal with the aid of real world sample proposal components •Understand the process of contracting•Position your project for a follow-on Phase II contract This book provides a practical, step by step process to get you from a concept to an actual proposal, while arming you with the knowledge needed to successfully execute and position yourself for a Phase II award. The sequential chapters allow one to: 1.Understand the basics of the program and answer the pressing questions you may have, such as: a.Am I eligible? b.What do I give up? c.Who owns the intellectual property? 2.Complete all required entity registrations prior to proposal submission 3.Introduction to the BAA and topic solicitations 4.Present my method for getting a potential solicitation created for your solution 5.Learn about the role and requirements of the principal investigator 6.Detailed and step by step instructions on proposal generation to include requirements, tips, formats and a sample of the sections 7.How to upload your proposal into the DoD SBIR portal 8.Provide our history of contracting so you are better prepared 9.I provide some recommendations on executing your Phase I project to better position your project for Phase II consideration 10.Finally, a glossary to help navigate all relevant acronyms For more information and resources visit us at www.sbirguide.com