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Book Categories |
1 | The path from bench to bedside | 1 |
2 | How did the FDA get to be in charge? : the history of regulation of human drugs | 13 |
3 | The eureka moment : how new medicines are discovered | 21 |
4 | Test tube results are not enough : animal tests for a drug's utility | 37 |
5 | The business decisions : committing to development | 47 |
6 | Production of the new drug | 57 |
7 | Laboratory and animal safety testing | 65 |
8 | Getting set for clinical trials | 81 |
9 | Phase 1 clinical trials | 93 |
10 | Phase 2 clinical testing | 101 |
11 | Phase 3 testing | 113 |
12 | Putting together the application for approval : the new drug application (NDA) | 123 |
13 | Everybody holds their breath : will the FDA file the NDA? | 135 |
14 | The FDA review | 143 |
15 | What do outside experts think? : the advisory committee meeting and FDA approval | 161 |
16 | The launch : marketing the drug | 181 |
17 | It's not over till it's over : post-approval studies | 201 |
18 | Are we (well) served? do we have the system, industry, and regulations we need, want, and deserve? | 223 |
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Add New Medicines: How Drugs Are Created, Approved, Marketed and Sold, Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regar, New Medicines: How Drugs Are Created, Approved, Marketed and Sold to the inventory that you are selling on WonderClubX
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Add New Medicines: How Drugs Are Created, Approved, Marketed and Sold, Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regar, New Medicines: How Drugs Are Created, Approved, Marketed and Sold to your collection on WonderClub |