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001    122938558 
003    OCoLC 
005    20200921045103.8 
006    m     o  d         
007    cr cnu---unuuu 
008    070411s2006    flu     ob    001 0 eng d 
020    9781420039146 
020    1420039148 
035    Taylor & Francis All eBooks 
035    (OCoLC)122938558|z(OCoLC)317752849|z(OCoLC)648165421
       |z(OCoLC)748520523|z(OCoLC)779913861 
037    TANDF_188166|bIngram Content Group 
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050  4 RM301.27|b.E37 2006eb 
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082 04 615/.704/0287|222 
245 00 Clinical trials of drugs and biopharmaceuticals /|c[edited
       by] Chi-Jen Lee [and others]. 
260    Boca Raton, FL :|bCRC Press/Taylor & Francis,|c2006. 
300    1 online resource (500 pages) 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
500    Revised edition of: Handbook of phase I/II clinical drug 
       trials. 1997. 
504    Includes bibliographical references and index. 
505 0  Drug discovery and preclinical research / Chi-Jen Lee [and
       others] -- The pharmaceutical background / Shri C. Valvani
       -- The pharmacological background for drug evaluation / 
       Lucia H. Lee [and others] -- Animal tests as predictors of
       human response / Peter I. Folb -- Worldwide regulatory 
       agencies / Christopher L. Wu, Benjamin R. Lee, and Mei-
       Ling Chen -- Decision points in drug development / Lucia 
       H. Lee [and others] -- Management of clinical development 
       costs / Mark Hovde -- Ethical aspects and good clinical 
       practice / Lucia H. Lee [and others] -- Investigational 
       new drug application and the licensure approval process / 
       Lucia H. Lee [and others] -- Clinical trials from Phase I 
       to Phase IV / Lucia H. Lee [and others] -- The assessment 
       of pharmacokinetics in early-phase drug evaluation / Paul 
       E. rolan and Valaria Molnar. 
505 0  Drug interactions / Lucia H. Lee [and others] -- 
       Antianginal drugs / Nancy C. Pauly and Edmond Roland -- 
       Antihypertensive drugs / W. Stephen Waring and David J. 
       Webb -- Drugs for treatment of stroke / Mariola Soehngen, 
       Wolfgang Soehngen, and Yasir Al-Rawi -- Antiasthmatic 
       drugs / Lucia H. Lee [and others] -- Anxiolytics and 
       hypnotics / Graham R. McClelland and Georges Moroz -- 
       Antidepressants / Lucia H. Lee [and others] -- Drugs for 
       Alzheimer's disease and other dementias / Benjamin R. Lee 
       [and others] -- Antiulcer drugs / Benjamin R. Lee [and 
       others] -- Diuretics / Hitesh H. Shah, Pravin C. singhal, 
       and Joseph Mattana -- Medical therapy of benign prostatic 
       hyperplasia / Benjamin R. Lee. 
505 0  Drugs for the treatment of specific skin diseases / 
       Muzlifah A. Haniffa [and others] -- Drugs for the 
       treatment of atopic eczema / Christopher L. Wu [and 
       others] -- Drugs for treatment of disorders of lipid 
       metabolism / Christopher L. Wu [and others] -- 
       Antidiabetic drugs / Christopher L. Wu [and others] -- 
       Antibiotics / Lucia H. Lee [and others] -- Antiviral drugs
       / Lucia H. Lee [and others] -- Anticancer drugs / Robert 
       E. Martell, Christiane Langer, and Renzo Canetta -- 
       Analgesics / Christopher L. Wu, Robert W. Hurley, and 
       Joseph W. Stauffer -- Vaccines / Chi-Jen Lee [and others] 
       -- Herbal products as complementary and alternative 
       medicine / Chi-Jen Lee [and others] -- Biotechnology-
       derived pharmaceuticals / Chi-Jen Lee [and others] -- 
       Future perspectives in drug development / Christopher L. 
       Wu, Benjamin R. Lee, and Mei-Ling Chen -- Future 
       perspectives in biopharmaceutical development / Chi-Jen 
       Lee [and others]. 
506    Available only to authorized UTEP users. 
520    The pharmaceutical industry is on the verge of an exciting
       and challenging century. Advances in pharmaceutical 
       sciences have dramatically changed the processes of 
       discovery and development of new therapeutic drugs and, in
       turn, resulted in an extraordinary increase in the 
       potential prophylactic and therapeutic interventions. In 
       this atmosphere, an intimate understanding of the 
       mechanisms of pharmacokinetic and pharmacodynamic activity
       and the processes of drug evaluation is essential. 
       "Clinical Trials of Drugs and Biopharmaceuticals" provides
       an overview of current procedures and major issues 
       involved in drug and biopharmaceutical development. The 
       book examines critical biochemical and pharmaceutical 
       considerations for trials conducted during each phase of 
       clinical development. It also reports information related 
       to early pre-clinical evaluations of pharmacological 
       activities and safety before proceeding with initiation of
       clinical trials.; The sections focus on clinical 
       assessments of drugs and biopharmaceuticals such as 
       cardiovascular, respiratory, central nervous system, 
       gastrointestinal and liver, genitourinary, skin, 
       metabolism, and chemotherapeutic drugs as well as vaccines,
       biotechnology-derived therapeutics, and plant-based 
       medicines. Practical and informative, this step-by-step 
       guide includes information on all four phases of clinical 
       trials prior to licensure and covers the design of post-
       marketing studies. The editors examine how recent advances
       and increased demand for safer and more effective drugs 
       have changed the process by which drugs are developed and 
       approved. 
588 0  Print version record. 
650  0 Drugs|xTesting. 
650  0 Clinical trials. 
650 12 Drug Evaluation|xmethods. 
650 22 Clinical Trials, Phase I as Topic|xmethods. 
650 22 Clinical Trials, Phase II|xmethods. 
650 22 Clinical Trials, Phase III|xmethods. 
650 22 Clinical Trials, Phase IV|xmethods. 
700 1  Lee, Chi-Jen. 
730 0  Handbook of phase I/II clinical drug trials. 
776 08 |iPrint version:|tClinical trials of drugs and 
       biopharmaceuticals.|dBoca Raton, FL : CRC Press/Taylor & 
       Francis, 2006|z0849321859|z9780849321856|w(DLC)  
       2005043902|w(OCoLC)58789493 
856 40 |uhttp://0-www.taylorfrancis.com.lib.utep.edu/books/
       9780429124198|zTo access this resource 
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