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This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require.
Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California's Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.
About the Author
Editor
Shayne C. Gad, BS (Whittier College, Chemistry and Biology, 1971) and PhD in Pharmacology/
Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-five-yearold
consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical
companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at
Searle, Synergen, and Beckton Dickinson. He has published 50 books and more than 350 chapters,
articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and
safety assessment. He has more than 40 years of broad-based experience in toxicology, drug and
device development, statistics, and risk assessment. He has specific expertise in neurotoxicology,
in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology.
Past president of the American College of Toxicology, the Roundtable of Toxicology
Consultants, and three of SOT's (Society of Toxicology) specialty sections. He has direct involvement
in the preparation of Investigational New Drug applications (INDs, 115 successfully to date), New
Drug Application (NDA), Product License Application (PLA), Abbreviated New Drug Application
(ANDA), 501(k), Investigational Device Exemption (IDE), Common Technical Document (CTD),
clinical data bases for phase 1 and 2 studies, and Premarket Approval Applications (PMAs). He has
consulted for the Food and Drug Administration (FDA), Environmental Protection Agency (EPA),
and National Institutes of Health (NIH), has trained reviewers, and has been an expert witness for
the FDA. He has also conducted the triennial toxicology salary survey as a service to the profession
for the last 29 years.
Dr. Gad is also a retired Navy officer with more than 26 years in service.
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Like it was written by George Santos
Received an Advanced Reader Copy from a friend. I am an avid true crime reader and upon completion I question if the author is credible. The timeline does not add up for his age and the times of his alleged involvement in organized crime. Some of the things in the book he is alleged to have said and done I remember almost word for word from movies I had previously watched. He literally stole a scene from the movie the accountant with Ben Affleck and said that he did it. I did a little research after completing the book and learned that this author was also claiming in 2010 that he was a long time member of the Bloods Gang. That coupled with the above leads me to believe that it is nothing more than fantasy. Do not waste your time or money
Like it was written by George Santos
Received an Advanced Reader Copy from a friend. I am an avid true crime reader and upon completion I question if the author is credible. The timeline does not add up for his age and the times of his alleged involvement in organized crime. Some of the things in the book he is alleged to have said and done I remember almost word for word from movies I had previously watched. He literally stole a scene from the movie the accountant with Ben Affleck and said that he did it. I did a little research after completing the book and learned that this author was also claiming in 2010 that he was a long time member of the Bloods Gang. That coupled with the above leads me to believe that it is nothing more than fantasy. Do not waste your time or money
What a difficult story to tell. I appreciate the honesty and vulnerability. Definitely made me think.
I had hopes for this book but was not expecting what I would read within the pages. If your kink is deplorable grammar, incoherent sentences, and inconsistent messages, then this book is for you. At first, I thought the book I received was not the book I ordered. But as I dived in, it was very confusing. I would not recommend this book to anyone
There are not many reviews on the internet for this book. In researching the many stores selling the book, it was self-published which makes a lot of sense. The online description is written perfectly, so reading the actual book was very difficult. Pages two and three are written clearly as well as the table of contents. Pages 155 and 156 are also written logically.
It appears this book was written, then sent through a program like “Grammarly.” Once completed it seems it was published without being re-read or edited. The first clue was the title narrative that used “Has” instead of “As.” The table of contents is one page off from what it shows on pages four though seven. Many of the “q’s” are written as “[]”
Below are some examples of what was within the pages of this book written verbatim:
“Chains & Discipline/ Domination & entry/ Sadism & Masochism (BDSM) is a wide classification of bed room play.” Page 9
“When bringing up the topic of chains, you are actually asking a person to offer you their depend on, their flexibility, and also possibly their suggestion of security in exchange for sensual/sexual enjoyment, power-play, and also feasible re-evaluation of your very own connection.” Page 39
“Techni[]ue can take a selection of kinds and also be as easy or facility as you pick to (new paragraph) bargain for your details scenario” Page 52
“BDSM stands for chains as well as entry, technique and also supremacy as well as sadism and also masochism.” Page 125
“SHELF means Risk Aware Consensual Kink.” Page 130
“Approval is whatever.” Page 152
“your twist isn’t my twist, yet your twist is OKAY.” Page 153
“You can be a top, base, or button” Page 153
Good service, good book. Just what I was looking for! Thank you!