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1

Dose finding by the continual reassessment method. Boca Raton: Taylor & Francis, 2011.

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2

Anthony, Riley W., and Murray Patricia J, eds. Conducting clinical trials. New York: Plenum Medical Book Co., 1987.

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3

K, Reddy Indra, ed. Pharmaceutical and clinical calculations. 2nd ed. Lancaster: Technomic Pub. Co., 2000.

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4

M, Todd Catherine, ed. Nurse's clinical guide, dosage calculations. Springhouse, Pa: Springhouse Corp., 1991.

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5

Spriet, Alain. Good practice of clinical drug trials. Basel: Karger, 1992.

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6

Guide to clinical trials. New York: Raven Press, 1991.

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7

Medici, Geraldine Ann. Drug dosage calculations: A guide for clinical practice. 2nd ed. Norwalk, Conn: Appleton & Lange, 1988.

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8

Introduction to clinical pharmaceutics. London: Pharmaceutical Press, 2009.

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9

M, Marshall Sally, ed. Clinical calculations: With applications to general and specialty areas. 7th ed. St. Louis: Elsevier/Saunders, 2013.

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10

Antiviral drugs: From basic discovery through clinical trials. Hoboken, N.J: Wiley, 2011.

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11

Erickson, Belle. Nurse's clinical guide to dosage calculations. 2nd ed. Springhouse, Pa: Springhouse Corp., 1994.

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12

Hertzman, Marc. Clinical trials in psychopharmacology: A better brain. 2nd ed. Chichester, West Sussex, UK: Wiley-Blackwell, 2010.

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13

Knight, Richardson Judith, ed. The mathematics of drugs and solutions with clinical applications. 3rd ed. New York: McGraw-Hill, 1985.

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14

Human experimentation: Methodologic issues fundamental to clinical trials. Dordrecht: Kluwer Academic Publishers, 1999.

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15

Symposium, Esteve Foundation. Optimal dose identification: Proceedings of the Esteve Foundation Symposium IX, Lloret de Mar (Girona), Spain, 4-7 October 2000. Edited by Breckenridge Alasdair. Amsterdam: Excerpta Medica, 2001.

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16

Meinert, Curtis L. Clinical trials handbook: Design and conduct. Baltimore, MD: Wiley, 2013.

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17

L, Beizer Judith, and Higbee Martin D, eds. Geriatric dosage handbook: Including clinical recommendations and monitoring guidelines. Hudson, Ohio: Lexi-Comp, 2010.

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18

Ascione, Frank J. Principles of scientific literature evaluation: Critiquing clinical drug trials. Washington, D.C: American Pharmaceutical Association, 2001.

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19

Methodology of clinical drug trials. 2nd ed. Basel: Karger, 1994.

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20

Corporation, Pharma, ed. Key statistical concepts in clinical trials for Pharma. New York: Springer, 2012.

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21

Hsü, Tuan-cheng. Computer analysis of sequential medical trials. New York: Ellis Horwood, 1990.

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22

Medical, Data International Inc. Markets, trends & opportunities in the clinical trials industry. Santa Ana, Calif. (5 Hutton Centre Dr., Suite 1100 Santa Ana, California 92707): Medical Data International, 1999.

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23

Dodds, Linda J. Drugs in use: Clinical case studies for pharmacists. 4th ed. London: Pharmaceutical Press, 2010.

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24

Drugs in use: Clinical case studies for pharmacists. 4th ed. London: Pharmaceutical Press, 2010.

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25

Controversial statistical issues in clinical trials. Boca Raton: CRC Press, 2011.

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26

United States. Food and Drug Administration. Why volunteer?: Clinical trials of medical treatments. Rockville, MD (5600 Fishers Lane, Rockville, 20857): Dept. of Health and Human Services, Food and Drug Administration, 2001.

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27

United States. Food and Drug Administration. Why volunteer?: Clinical trials of medical treatments. Rockville, MD (5600 Fishers Lane, Rockville, 20857): Dept. of Health and Human Services, Food and Drug Administration, 2001.

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28

United States. Food and Drug Administration. Why volunteer?: Clinical trials of medical treatments. Rockville, MD (5600 Fishers Lane, Rockville, 20857): Dept. of Health and Human Services, Food and Drug Administration, 2001.

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29

Robinson, Martin. Clinical trials risk management. Boca Raton, FL: CRC/Taylor & Francis, 2006.

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30

Binary data analysis of randomized clinical trials with noncompliance. Chichester, West Sussex, United Kingdom: John Wiley & Sons Inc., 2011.

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31

Baumler, Marian. Dose escalation schemes for phase I clinical trials for discrete observations. 1988.

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32

Jean-Michel, Métry, and Meyer Urs A. 1964-, eds. Drug regimen compliance: Issues in clinical trials and patient management. Chichester: Wiley, 1999.

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33

Kee, Joyce LeFever. Clinical calculations. W.B. Saunders, 1988.

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34

(Editor), Derek Pearson, and Colin G. Miller (Editor), eds. Clinical Trials in Osteoporosis (Clinical Trials). 2nd ed. Springer, 2007.

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35

Tweed. Clinical Trials. Taylor & Francis, 1999.

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36

Gad, Shayne Cox. Clinical Trials Handbook. Wiley & Sons, Incorporated, John, 2009.

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37

Iversen, Les. 5. Making new medicines. Oxford University Press, 2016. http://dx.doi.org/10.1093/actrade/9780198745792.003.0005.

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‘Making new medicines’ outlines the process of developing and marketing new drugs. Advanced techniques provide scientists with many potential receptor targets. Compounds which may affect the target are tested in vitro. If they appear to work further tests are carried out, increasing in complexity from cells to whole organisms. Animal trials help forecast toxicity and determine dosages. Finally, three-phase clinical trials occur in humans. Pharmaceutical companies then submit their data to the government for approval, before the drug can be sold. The lengthy and expensive process often results in high drug prices. A relatively new class of medicines—monoclonal antibodies—is having a major impact in treating hitherto untreatable conditions.
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38

E, Salvaggio John, Shaw Jane E, Fisher Robert S, and Neu Harold C. 1934-, eds. Immunology and monoclonal antibodies. Mount Kisco, N.Y: Futura Pub. Co., 1985.

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39

Clinical Nursing Calculations. Jones & Bartlett Learning, LLC, 2015.

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40

Sienkiewicz, Susan, and Sandra Megerdichian. Clinical Nursing Calculations. Jones & Bartlett Learning, LLC, 2019.

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41

Doutremepuich, C. Ultra low doses: Biological and clinical applications. Informa Healthcare, 1991.

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42

(Editor), Chi-Jen Lee, Lucia H. Lee (Editor), Christopher L. Wu (Editor), Benjamin R. Lee (Editor), and Mei-Ling Chen (Editor), eds. Clinical Trials of Drugs and Biopharmaceuticals. CRC, 2005.

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43

Lee, Lucia H., Christopher L. Wu, Chi-Jen Lee, Benjamin R. Lee, and Mei-Ling Chen. Clinical Trials of Drugs and Biopharmaceuticals. Taylor & Francis Group, 2005.

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44

Hutchinson, David. How Drugs Are Developed (Clinical Trials). Brookwood Medical Pubns, 1998.

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45

Chi-Jen, Lee, ed. Clinical trials of drugs and biopharmaceuticals. Boca Raton, FL: CRC Press/Taylor & Francis, 2006.

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46

Clinical drug trials and tribulations. 2nd ed. New York: Marcel Dekker, 2002.

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47

Reddy, Indra K., and Mansoor A. Kahn. Pharmaceutical and Clinical Calculations, 2nd Edition. 2nd ed. CRC, 2000.

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48

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial design. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0014.

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This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is identified Elimination of bias is critical to the study design and methods of eliminating bias are discussed, defining the population, randomisation and blinding. A summary of the elements to be considered when designing a study are presented including the types of control, placebo or active, and their uses, Non comparative and comparative designs are presented. In the comparative design both within and between patient designs are discussed including crossover, parallel, sequential, factorial and left right comparisons. Patient outcomes measures as well as efficacy measurement are required for new treatments. There is a brief review of pharmaeconomic study designs. Other types of study design, dose escalation and dose response studies are also discussed. As well as reducing bias in studies another critical element is the recording of the primary assessment methods. The choice of methods will affect other aspects of the study such as the statistical considerations. The methodology must be standardised and validated.
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49

Bennell, Kim L., Ans Van Ginckel, Fiona Dobson, and Rana S. Hinman. Exercise for the person with osteoarthritis. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199668847.003.0022.

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Because of its beneficial effects on pain and physical dysfunction commonly reported by afflicted individuals, all clinical guidelines of osteoarthritis (OA) advocate exercise therapy as a vital component of conservative management strategies. Although the optimal exercise modalities in terms of dosage, exercise type, or delivery mode are not yet known, clinical benefits can be achieved with a wide range of exercise types. While treatment effect sizes may be considered small to moderate, they are similar to those of common analgesic drugs or oral non-steroidal anti-inflammatories but seem to elicit fewer side effects. To achieve optimal treatment outcomes, programme parameters should be individualized to the patient’s clinical characteristics and preferences. Where validated instruments could assist the clinician in monitoring the progress of an exercise intervention programme, adherence to exercise in the longer term is a prerequisite to maintain symptom relief over time. Whereas the current body of evidence mainly comprises clinical trials in people with knee OA, future studies should continue to address efficacy and safety of exercise therapy in individuals suffering from hand or hip OA and should further determine its ability to postpone the need for costly arthroplasty surgery.
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50

1948-, Gad Shayne C., ed. Clinical trials handbook. Hoboken, N.J: Wiley, 2009.

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