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| Preface | ||
| Contributors | ||
| 1 | The Preclinical Research Process | 3 |
| 2 | The Commercial Development Process | 5 |
| 3 | What's Involved in Clinical Research? | 9 |
| 4 | Product Development Partnership: Role of Academia and the NIH | 17 |
| 5 | Identifying Funding Opportunities at the NIH: A Grants Perspective | 21 |
| 6 | Identifying Funding Opportunities at the NIH: A Contract Perspective | 25 |
| 7 | Role of the Institution in Furthering the Young Investigator | 33 |
| 8 | Role of Toxicology in Drug Discovery and Development | 47 |
| 9 | Pharmacokinetics Study | 49 |
| 10 | Formulation of Dosage Forms | 51 |
| 11 | Polymeric Drug Delivery Systems | 53 |
| 12 | What Is a Drug, a Device, a Biological? | 69 |
| 13 | Understanding the Organization and Function of the FDA | 75 |
| 14 | How to Apply for an IND | 81 |
| 15 | What Is a 501(k) and a PMA? | 87 |
| 16 | Patenting and Licensing: An Overview of the Processes | 97 |
| 17 | Pharmaceutical Clinical Development | 103 |
| 18 | FDA Recommendations for Drug Safety Testing | 115 |
| 19 | Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation | 119 |
| 20 | What Is Involved in a New Drug Application? | 133 |
| 21 | Institutional Review Boards and Informed Consent | 141 |
| 22 | Postmarketing Surveillance: A Brief Synopsis of Its History and Current Direction | 147 |
| 23 | I Had an Idea, and I Made It Work: Here's How | 159 |
| 24 | Working with Companies to Market Your Discoveries | 165 |
| 25 | Developing Information for Health-Care Decision Makers | 167 |
| 26 | Getting a Medical Products Business Started | 169 |
| 27 | From Start-Up to Initial Public Offering | 179 |
| Author Index | 189 | |
| Subject Index | 191 |
| Price | Condition | Delivery | Seller | Action |
| $220.15 | Digital |
| WonderClub |
Jeff Myers
reviewed Idea to Product: The Process on December 21, 2011
Idea to Product
Mirror neurons are fascinating.. they show that we're more connected to each other than once believed. Mirror neurons might be the root of empathy.
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Add Idea to Product: The Process, The young investor with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market and has little knowledge of the steps in the development of new drugs, diagnostics, or devices. This volume contain, Idea to Product: The Process to the inventory that you are selling on WonderClubX
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Add Idea to Product: The Process, The young investor with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market and has little knowledge of the steps in the development of new drugs, diagnostics, or devices. This volume contain, Idea to Product: The Process to your collection on WonderClub |