Some further thoughts about the direction of the innovator pharmaceutical business
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The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients | Some further thoughts about the direction of the innovator pharmaceutical business | newdrugsbook.wordpress.com Reviews
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Some further thoughts about the direction of the innovator pharmaceutical business
newdrugsbook.wordpress.com
Pharma Mergers and Acquisitions: No-win or a No-Lose Propositions | The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients
https://newdrugsbook.wordpress.com/2014/04/28/pharma-mergers-and-acquisitions-no-win-or-a-no-lose-propositions
The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients. Some further thoughts about the direction of the innovator pharmaceutical business. Thoughts About Alzheimer’s Disease Therapeutics. Why I Wrote this Book. Pharma Mergers and Acquisitions: No-win or a No-Lose Propositions. April 28, 2014. Lawrence Friedhoff, MD, PhD, FACP. The cost is minimal because the money Company A spends to acquire Company B is counted as an investment. Compa...
The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients | Some further thoughts about the direction of the innovator pharmaceutical business | Page 2
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The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients. Some further thoughts about the direction of the innovator pharmaceutical business. Thoughts About Alzheimer’s Disease Therapeutics. Why I Wrote this Book. Newer posts →. Long Drug Approval Times for Central Nervous System Drugs. March 23, 2012. Lawrence Friedhoff, MD, PhD, FACP. I saw an interesting news article. Treatments had ever been approved. Thus, the requirements for FDA ap...
Changes at Merck | The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients
https://newdrugsbook.wordpress.com/2014/01/02/changes-at-merck
The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients. Some further thoughts about the direction of the innovator pharmaceutical business. Thoughts About Alzheimer’s Disease Therapeutics. Why I Wrote this Book. Indian Patent Decision – A Spur to Innovation. Pharma Mergers and Acquisitions: No-win or a No-Lose Propositions →. January 2, 2014. Lawrence Friedhoff, MD, PhD, FACP. Is a former Merck employee suggesting that he may have trouble c...
Lawrence Friedhoff, MD, PhD, FACP | The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients
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The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients. Some further thoughts about the direction of the innovator pharmaceutical business. Thoughts About Alzheimer’s Disease Therapeutics. Why I Wrote this Book. Author Archives: Lawrence Friedhoff, MD, PhD, FACP. About Lawrence Friedhoff, MD, PhD, FACP. Pharma Mergers and Acquisitions: No-win or a No-Lose Propositions. April 28, 2014. Generally Accepted Accounting Principles. January 2, 2014.
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clinicaltrialist.wordpress.com
(Don’t) Blame the Chemists | clinicaltrialist
https://clinicaltrialist.wordpress.com/productivity/dont-blame-the-chemists
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? Don’t) Blame the Chemists. Couple of days ago, I was talking to a medicinal chemist about why drug development productivity might have decreased. I pushed him to explain and here is what he said. 1) good chemists can get you good compounds against any target. But is that the way it should be? Are they doing their job if they ...
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Productivity | clinicaltrialist
https://clinicaltrialist.wordpress.com/productivity
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? This section contains pages on drug development productivity. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, and Space. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). Notify me of new comments via email.
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Whence the Low Productivity? | clinicaltrialist
https://clinicaltrialist.wordpress.com/productivity/whence-the-low-productivity
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? Whence the Low Productivity? One of the most intractable problems in drug development has been productivity. Now, it is very difficult to discern what factor plays what role in productivity, since there are few controls to compare against. So for the most part, the debates are based on opinions. Yes, their costs have been goi...
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Braess’s Paradox | clinicaltrialist
https://clinicaltrialist.wordpress.com/paradoxes/braesss-paradox
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? In 1990, New York City closed 42nd Street in observance of Earth Day (1). The 42nd Street is a major thoroughfare, and its closure was expected by many to be a disaster. Manhattan’s traffic is bad enough on an ordinary day: surely the closure of a major artery could only make it worse. In other cases, it is because we mistake...
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Managing CROs 101 | clinicaltrialist
https://clinicaltrialist.wordpress.com/clinical/managing-cros-101
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? You can’t just sign a check and expect the CRO to deliver what you want. I guarantee that if you do that they will not deliver. They are not mind readers. And they don’t always have their economic incentives aligned with yours. One Response to “Managing CROs 101”. March 1, 2014 at 2:10 am. This assessment is spot-on and a gre...
clinicaltrialist.wordpress.com
About | clinicaltrialist
https://clinicaltrialist.wordpress.com/about-2
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? I am a physician by training (Harvard Medical School, Barnes Hospital), and in addition, a lawyer by training as well (albeit in British law, at Oxford, under a Rhodes Scholarship). I have a lot of experience in drug development, including dozens of INDs and numerous NDA/BLA/MAA/etc. One Response to “About”. You are commentin...
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Small Sample Size Paradox | clinicaltrialist
https://clinicaltrialist.wordpress.com/paradoxes/small-sample-size-paradox
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? Small Sample Size Paradox. Small Sample Size Illusion is an illusion that will eventually make it into my next iteration of the cognitive optical illusions slide set, but in the meanwhile, I am posting it on the blog. So how does this apply to clinical trial interpretation? Often in a journal article, you will see a graph lik...
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Reducing Sample Size | clinicaltrialist
https://clinicaltrialist.wordpress.com/clinical/sample-size
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? How to Reduce Sample Size for Clinical Trials. One of the questions you will often be asked if you’re a clinical trialist is: “Can’t we make the study smaller? Use a Continuous Variable. A continuous variable has much greater information content than a non-continuous variable. When you know someone’s blood pressure ...Sometim...
clinicaltrialist.wordpress.com
Castalia, Kinetics, Space | clinicaltrialist
https://clinicaltrialist.wordpress.com/productivity/castalia-kinetics-space
Why Clinical Trials Fail. Whence the Low Productivity? Don’t) Blame the Chemists. Castalia, Kinetics, Space. Small Sample Size Paradox. Terra Incognita of Science. What’s in a Name? Castalia, Kinetics, Space. In a novel,. But unfortunately, their accomplishments are irrelevant to the real world and they accomplish nothing. In addition to tearing apart the models used in drug development, he made a couple of important points. The first is that animal models can be great at deciphering normal physiolog...
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The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients | Some further thoughts about the direction of the innovator pharmaceutical business
The Book – New Drugs: An Insider's Guide to the FDA's New Drug Approval Process, For Scientists, Investors and Patients. Some further thoughts about the direction of the innovator pharmaceutical business. Thoughts About Alzheimer’s Disease Therapeutics. Why I Wrote this Book. Pharma Mergers and Acquisitions: No-win or a No-Lose Propositions. April 28, 2014. Lawrence Friedhoff, MD, PhD, FACP. The cost is minimal because the money Company A spends to acquire Company B is counted as an investment. Compa...
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