rahul_hi1234
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2007-04-03 13:34

Posting: # 613
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 Idea of trial design [Design Issues]

please any one tell me about the literature on trial design to available


Edit: Please follow the Forum’s Policy[Helmut]
Helmut
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2007-04-03 14:26

@ rahul_hi1234
Posting: # 615
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 References for trial designs

Dear Rahul,

just a list of textbooks published within the last ten years:
  1. Hauschke D, Steinijans V, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: Wiley; 2007.
  2. Patterson S, Jones B. Bioequivalence and Statistics in Clinical Pharmacology. Boca Raton: Chapman & Hall/CRC; 2006.
  3. Matthews JNS. Introduction to Randomized Controlled Clinical Trials. Boca Raton; Chapman & Hall/CRC: 2nd ed. 2006.
  4. Senn S. Statistical Issues in Drug Development. Chichester; Wiley: 1997, reprint with corrections 2004.
  5. Bolton S, Bon C. Pharmaceutical Statistics. New York; Marcel Dekker: 4th ed. 2004.
  6. Jones B, Kenward MG. Design and Analysis of Cross-over Trials. Boca Raton; Chapman & Hall/CRC: 2nd ed. 2003.
  7. Wellek S. Testing Statistical Hypotheses of Equivalence. Boca Raton; Chapman & Hall/CRC: 2003.
  8. Senn S. Cross-over Trials in Clinical Research. Chichester; Wiley: 2nd ed. 2002.
  9. Millard SP, Krause A, editors. Applied Statistics in the Pharmaceutical Industry. New York; Springer: 2001.
  10. Chow S-C, Liu J-p. Design and Analysis of Bioavailability and Bioequivalence Studies. New York; Marcel Dekker: 2nd ed. 2000.
  11. Chow S-C, Liu J-p. Design and Analysis of Clinical Trials. Chichester; Wiley: 1998.
Textbooks given above are more or less leaning towards statistics.

A more guideline-driven overview of approaches is given by
  • Amidon G, Lesko L, Midha K, Shah V, Hilfinger J, editors. International Bioequivalence Standards: A New Era. Ann Arbor; TSRL: 2006.
Of course, you will need some background in PK/PD and NCA as well, e.g.,
  1. Gibaldi M, Perrier D. Pharmacokinetics. New York; Marcel Dekker: 3rd ed. 2006.
  2. Gabrielsson J, Weiner D. Pharmacokinetic an Pharmacodynamic Data Analysis: Concepts and Applications. Stockholm: Swedish Pharmaceutical Press; 3rd ed. 2000.
  3. Cawello W, editor. Parameters for Compartment-Free Pharmacokinetics. Aachen: Shaker-Verlag; 2003.

Cheers,
Helmut Schütz
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