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9780275981419

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Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry's new marketing techniques. -SciTech Book News Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA's processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview. -Midwest Book Review/California Bookwatch With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, Are We (Well) Served? the author gives her opinion of the drug approval process, concluding, We are doing pretty well. Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers. -Choice ?Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA's processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview.?-Midwest Book Review/California Bookwatch ?Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry's new marketing techniques.?-SciTech Book News ?This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions....[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much.?-AORN Journal ?With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, Are We (Well) Served? the author gives her opinion of the drug approval process, concluding, We are doing pretty well. Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers.?-Choice This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions....[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much. -AORN Journal The author does all the heavy lifting, laying out the important points and context in a coherent narrative that maximizes reader comprehension. Given the broad scope of the topic and the moderate length of the book, the chapters on clinical research are remarkably informative. The book is ideal for clinical research professionals who want to see the forest through the trees of study and case report forms. -Journal of Clinical Research Best Practices

The author does all the heavy lifting, laying out the important points and context in a coherent narrative that maximizes reader comprehension. Given the broad scope of the topic and the moderate length of the book, the chapters on clinical research are remarkably informative. The book is ideal for clinical research professionals who want to see the forest through the trees of study and case report forms. -Journal of Clinical Research Best Practices

Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry's new marketing techniques. -SciTech Book News Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA's processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview. -Midwest Book Review/California Bookwatch With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, Are We (Well) Served? the author gives her opinion of the drug approval process, concluding, We are doing pretty well. Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers. -Choice ?Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry's new marketing techniques.?-SciTech Book News ?This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions....[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much.?-AORN Journal ?Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA's processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview.?-Midwest Book Review/California Bookwatch ?With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, Are We (Well) Served? the author gives her opinion of the drug approval process, concluding, We are doing pretty well. Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers.?-Choice This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions....[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much. -AORN Journal The author does all the heavy lifting, laying out the important points and context in a coherent narrative that maximizes reader comprehension. Given the broad scope of the topic and the moderate length of the book, the chapters on clinical research are remarkably informative. The book is ideal for clinical research professionals who want to see the forest through the trees of study and case report forms. -Journal of Clinical Research Best Practices

Author Information

Bernice Schacter Ph.D., has over 25 years of biomedical research experience in both academia and industry. She served on the faculty of the School of Medicine of Case Western Reserve University and conducted immunology research at Bristol-Myers Squibb Company. She also served as Vice President of Research at BioTransplant, Inc., a biotechnology startup company in Boston, MA. She has published over 50 papers in peer-reviewed journals and is a co-inventor on four issued patents. Since 1994 she has been a biomedical consultant and writer. She has taught immunology to undergraduate, graduate, and medical students and has developed and offered biotechnology courses for liberal studies students at Wesleyan University in Connecticut and at the University of Delaware.

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