LEADER 00000pam a22005054a 4500 
001    ocm60839355 
005    20060510120905.0 
008    050706s2006    ctu      b    001 0 eng   
010      2005019187 
016 7  101251830|2DNLM 
020    027598141X|qalkaline paper 
035    (OCoLC)ocm60839355 
035    409628 
040    DNLM/DLC|beng|cDLC|dNLM|dBAKER|dC#P|dIXA|dRID 
042    pcc 
049    RIDM 
050 00 RM301.25|b.S34 2006 
082 00 615/.19|222 
090    RM301.25 .S34 2006 
100 1  Schacter, Bernice,|d1943-2008.|0https://id.loc.gov/
       authorities/names/n86844685 
245 14 The new medicines :|bhow drugs are created, approved, 
       marketed, and sold /|cBernice Schacter. 
264  1 Westport, Conn. :|bPraeger,|c2006. 
300    xi, 267 pages ;|c25 cm 
336    text|btxt|2rdacontent 
337    unmediated|bn|2rdamedia 
338    volume|bnc|2rdacarrier 
504    Includes bibliographical references (pages 237-257) and 
       index. 
505 0  The path from bench to bedside -- How did the FDA get to 
       be in charge? The history of regulation of human drugs -- 
       The eureka moment: how new medicines are discovered -- 
       Test tube results are not enough: animal tests for a 
       drug's utility -- The business decisions: committing to 
       development -- Production of the new drug -- Laboratory 
       and animal safety testing -- Getting set for clinical 
       trials -- Phase 1 clinical trials -- Phase 2 clinical 
       testing -- Phase 3 testing -- Putting together the 
       application for approval: the new drug application (NDA) -
       - Now everybody holds their breath (and some people may 
       brush up on the rules for insider trading), will the FDA 
       file the NDA? -- The FDA review -- What do outside experts
       think? The advisory committee meeting and FDA approval -- 
       The launch-marketing the drug -- It's not over till it's 
       over: post approval studies -- Are we (well) served? Do we
       have the system of industry and regulations we need want 
       and may deserve. 
650  0 Drug development|0https://id.loc.gov/authorities/subjects/
       sh97007921|vPopular works.|0https://id.loc.gov/authorities
       /subjects/sh99001720 
650  0 Clinical trials|0https://id.loc.gov/authorities/subjects/
       sh85027069|vPopular works.|0https://id.loc.gov/authorities
       /subjects/sh99001720 
650  0 Pharmaceutical industry|0https://id.loc.gov/authorities/
       subjects/sh85039713|vPopular works.|0https://id.loc.gov/
       authorities/subjects/sh99001720 
650  0 Consumer education.|0https://id.loc.gov/authorities/
       subjects/sh85031483 
650  7 Drug development.|2fast|0https://id.worldcat.org/fast/
       898670 
650  7 Clinical trials.|2fast|0https://id.worldcat.org/fast/
       864429 
650  7 Pharmaceutical industry.|2fast|0https://id.worldcat.org/
       fast/1060129 
650  7 Consumer education.|2fast|0https://id.worldcat.org/fast/
       876300 
655  7 Popular works.|2fast|0https://id.worldcat.org/fast/1423846
856 41 |3Table of contents|uhttp://www.loc.gov/catdir/toc/
       ecip0515/2005019187.html 
901    MARCIVE 20231220 
935    409628 
994    C0|bRID