1

1.6 References (Chapter -1)

1. Eric Reid, Ian D., Wilson. Methodological Survey in Biochemistry and

Analysis. Analysis for drug and metabolites, including Anti-infective Agents.

20,1990, 1-57.

2. Hartmann, C., Smeyers-Verbeke, J., Massart, D.L., McDowall R.D. Validation

of bioanalytical chromatographic methods. Journal of Pharmaceutical and

Biomedical Analysis. 17(3), 1998, 193-218.

3. Bressolle, F., Bromet-Pitit, M., Audran, M. Validation of Liquid

Chromatography and Gas Chromatographic Methods Application to

Pharmacokinetics. Journal of Chromatography B. 686(1), 1996, 3-10.

4. U.S. Department of Health and Human Services. Food and Drug

Administration. Guidance for Industry, Bioanalytical Method Validation, May

2001.

5. Smith R.V., Stewart J.T. Textbook of Biopharmaceutics Analysis. Lea &

Febiger, Philadelphia, 1st edition 1981, 308.

6. Akira and Mikio Yashiki. Pretreatments of human specimens. Springer.

1(4),2005, 25-31.

7. Osamu Suzuki, Kanako Watanabe. Drugs and poisons in humans, A handbook

of practical analysis. Springer, 1st edition, 2005, 25-31.

Chapter 1 Introduction
 2

8. Lesley Smart, Separation, purification and identification. Royal Society of

Chemistry (Great Britain). 2002. ISBN: 978-0-85404-685-0.

9. Shah, P.V., Midha, K.K., Dighe, S., McGilveray, J. I, Skelly, P.J, Yacobi, A.,

Layloff, T., Viswanathan, C.T., Cook, E.C., McDowall, R.D., Pittman, A. K.,

Spector, S. Analytical Method Validation: Bioavailability, Bioequivalence and

Pharmacokinetics Studies, Journal of Pharmaceutical Sciences.16(4),1991,

245-55.

10. Braggio, S., Barnaby R.J., Grosi, P., Cugola M. A strategy for validation of

analytical methods. Journal of Pharmaceutical and Biomedical Analysis, 14(4)

1996, 375-388.

11. Karnes, H.T., Shiu, G., Shah, V.P. Validation of Bioanalytical Methods,

Pharmaceutical Research, 8(40), 1991, 221-225.

12. Breda, C.A., Bredam M., Frigerio, E. Bioanalytical method validation: A risk-

based approach? Journal of Pharmaceutical and Biomedical Analysis, 35(4),

2004, 887-89.

13. Nakashima Kenichiro. High-Performance Liquid Chromatography of drug of

abuse in biological samples. Journal of Health Science. 51(3), 2005, 272-277.

14. Boulanger, B., Chiap, P., Dewe, W., Crommen, J., Hubert, Ph. An analysis of

the SFSTP guide on validation of chromatographic bioanalytical methods:

Progresses and limitations. Journal of Pharmaceutical and Biomedical

Analysis. 32(4-5) ,2003, 753-765.

Chapter 1 Introduction
 3

15. Lang, J.R. Bolton, S. A Comprehensive Method Validation Strategy for

Bioanalytical Applications in the Pharmaceutical Industry – 3 Statistical

Analysis. Journal of Pharmaceutical and Biomedical Analysis. 9(6),2008 435-

442.

16. Hubert, Ph., Chiap, P., Crommena, J., Boulanger, B., Chapuzet, E., Mercier,

N., Bervoas-Martin, S., Chevalier, P., Grandjean, D., Lagorce, P., Lallier, M.,

Laparra, M.C., Laurentie, M., Nivet, J.C. The SFSTP guide on the validation

of chromatographic methods for drug bioanalysis: From the Washington

Conference to the laboratory. Analytica Chimica Acta 391(3)1999, 135-148.

17. Wieling, J., Hendriks, G., Tamminga, W.J., Hempenius, J., Mensink, C.K.,

Oosterhuis, B., Jonkman, J.H.G. Rational Experiment Design for Bioanalytical

Methods Validation Illustration Using an Assay Method for Total Captopril in

Plasma, Journal of Chromatography A., 730(1-2) 1996, 381-394.

18. Causon Roger. Validation of chromatographic methods in biomedical analysis

viewpoint and discussion. Journal of Chromatography B, 689(4)1997, 175-

180.

19. Jürgen Gross. Mass spectrometry: A textbook. Springer Publication, 1st

edition, 2004. ISBN: 978-3-540-40739-3

20. Jeffery, G.H., Basselt, J. Vogel’s Text Book of Quantitative Chemical

Analysis. John Wiley & Sons Inc., 5th Edition, 1991, 217-235.

Chapter 1 Introduction
 4

21. International Conference on Harmonization (ICH). Validation of Analytical

Methods: Definitions and Terminology. ICH Q2 A. 1994.

22. International Conference on Harmonization (ICH). Validation of Analytical

Methods: Methodology. ICH Q2 B. 1996.

23. Zhoua Shaolian, Songb Qi, Tangb Yong, Weng Naidonga. Critical Review of

Development, Validation, and Transfer for High Throughput Bioanalytical

LC-MS/MS Methods. Current Pharmaceutical Analysis. 1(5) 2005, 3-14.

24. Mohammad, A., Tabrizi-Fard, Ho-Leung, Fung. Reversed-phase high-

performance liquid chromatography method for the analysis of nitroarginine in

rat plasma and urine. Journal of Chromatography B.(6) 679, 1996, 7-12.

25. Bmscheck Torsten, Meyer Hartmut, Wellhrner Hans Herbert. A high-

performance liquid chromatographic assay for the measurement of

azathioprine in human serum samples. Journal of Chromatography B(4) 675,

1996, 287-294.

26. Kees Frieder, Jehnich Doris, Grobecker Horst. Simultaneous determination of

acetylsalicylic acid and salicylic acid in human plasma by high-performance

liquid chromatography. Journal of Chromatography B, 677(6) 1996, 172-177.

27. Raymond Naxing, Fan Leimin, Rieser Matthew J., Tawakol A. El-Shourbagy.

Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS.

Journal of Pharmaceutical and Biomedical Analysis, 44(2)2007, 342–355.

Chapter 1 Introduction
 5

28. Lau Yau Yi, Hanson Glenn D., Carel Barbara J. Determination of rifampin in

human plasma by high-performance liquid chromatography with ultraviolet

detection. Journal of Chromatography B, 676(3)1996 ,147- 152.

29. Compagnon P., Thiberville L., Moore N., Thudlez C., Lacroix C., Simple

high-performance liquid chromatographic method for the quantization of

5-fluorouracil in human plasma, Journal of Chromatography B,

677(2), 1996,

380-383.

Chapter - 3

1. Goldberg M.R, Lee .Y., Vyas.K.P., Slaughter.D.E., Panebianco.D.,

Ermlich.S.J., Shadle.C.R., Brucker.M.J., Mc Loughlin.D.A., Olah.T.V.

journal of clinical pharmacology. 40 (1), 2000, 74-83

2. Bou.J, Gras.J, Cortijo.J, Morcillo E.J, Llenas J, Palacios J.M,

Cephalagia. 21(8),2001, 804- 812.

3. Bou J, Domenech .T, Puig J, Heredia A, Gras J, Fernandez F.D, Beleta J

and Palacios J.M, Eur. J Pharmacology. 410(1), 2000, 33-41.

4. Joseph C.F, Jristi K.R, Josep M.J, Barabara J.C, David J.A.B,Moira T.B,

Nkechi E.A, Br. J. Clin Pharmacol 51(6) 2001, 437-441.

5. Dechant K.L,Clissold S.P, Sumatriptan. Drugs. 43(5), 1992, 776-798

6. Hay E, Rodrig J, Hussain A, Derazon H, Kopelovitch G, Dashkovsky E ,

Bokish N, Kafka M, Shtibelman I, Nassimyan S. J Emerg Med 25 (3),

2003, 245-249.

Chapter 1 Introduction
 6

7. Goldberg M.R, Sciberras D, Smet M.De, Lowry R, Tomasko L, Lee Y,

Olah T.V, Zhao J, Vyas K.P, Halpin R, Kari PH, James I. Br. J. Clin

Pharmacol 52(1),2001,69-76.

8. Musson D.G, Birk K.L, Panebianco D.L,Gagliano K.D, .Rogers J.D,

Goldberg M.R. Int J Clin Pharmacol Ther 39(10), 2001, 447-52.

9. Song M, Hang T, Zhao H, Wang L, Ge P, Ma P. Rapid Commun Mass

Spectrom.21(21) 2007, 3427-34.

10. Chen Y, Miao H, Lin M, Fan G, Hong Z, Wu H, Wu Y. J.Chromatogr B

Analyt Technol Biomed Life Sci. 844(2),2006, 268-277.

11. Guo J.F, Zhang A.J, Zhao L, Sun X.H, Zhao Y.M, Gao, H.Z Liu Z.Y,

Qiao S.Y. Biomed Chromatogr. 20 (11) , 2006, 61-66.

12. Vishwanathan K,.Bartlett M.G, Stewart J.T. Rapid Commun Mass

Spectrom 14 (3), 2000, 168-72.

13. Chen J, Jiang W.M, Xie Y.L, Jin L, Mei N, Liang X.G.

Arzneimittelforschung 55(7), 2005, 355-8.

14. Chen J, Jiang X.G, Jiang W.M, Gao X.L, Mei N, Pharmazie 60(1), 2005,

39 – 41.

15. Chen J, Jiang X, Jiang W, Mei N, Gao X, Zhang Q. J.Chromatogr B

Analyt Technol Biomed Life Sci 805(1), 2004,169-73.

16. Vyas K.P, Halpin R.A, Geer L.A, Ellis J.D, Liu L, Cheng H, Chavez-Eng

C, Matuszewski B.K, Varga S.L, Guiblin A.R, Rogers J.D. Drug Metab

Dispos 28(1) 2000, 89-95.

Chapter 1 Introduction
 7

17. McLoughlin D.A, Olah T.V, Ellis J.D,Gilbert J.D, Halpin R.A.

J.Chromatogr A .726 (1-2), 1996, 115-24.

18. Barrish A, Olah T.V, Gatto G.J, Michel K.B, Dobrinska M.R, Gilbert

J.D. Rapid Commun Mass Spectrom .10(9),1996, 1033-7.

19. Wang C, Quan L.H, Guo Y, Liu C.Y, Liao Y.H. Int J Pharm. 337(1-2)

2007, 155-60.

20. Raj T.J.S, Bharathi C.H, Kumar M.S, Prabahar J, Kumar P.N, Sharma H.K,

Parikh K. J.Pharm Biomed Anal 49(9), 2009,156-62.

21. Rao B.M, Sangaraju S, Srinivasu M.K, Madhavan P, LalitaDevi M,

Rajendra kumar P, Chandrasekhar K.B,.Arpitha CH, Satya Balaji T. J

Pharm Biomed Anal 41(4), 2006, 1146-51.

22. Guidance for industry: bioanalytical method validation, U.S. Department of

Health and Human Services, Food and Drug Administration, Center for

Drug Evaluation and Research (CDER), Center for Biologics Evaluation and

Research (CBER), May 2001.

23. Guidance for industry Food- effect bio availability and Fed Bio equivalence

studies. U.S. Department of Health and Human services Food and Drug

Administration Centre for Drug Evaluation and research (CDER) December

2002.

24. Guidance for industry Bio availability and Fed Bio equivalence Studies for

Orally Administered Drug Products-General considerations U.S.Department

of Health and Human services Food and Drug Administration Centre for

Drug Evaluation and research (CDER) March 2003

Chapter 1 Introduction
 8

25. Guidance for industry, statistical approaches to establishing bio-equivalence,

US FDA, Center for Drug Evaluation and Research 2001, 1-45.

26. http :// pkpd.kmu.edu.tw/bear

Chapter - 4

4.7 References
1. Coukell AJ, Spencer CM, Benfield P. CNS Drugs. 6(2),1996, 237–243 .

2. Costa J A Silva E. The public health impact of anxiety disorders: a WHO

perspective. Acta Psychiatrica Scandinavica. 17(2),1998, 2-5

3. Xiberas, J.L. Martinot, L. Mallet, E. Artiges, M. Canal, C. Loch, B.Maziere

and M.L.Paillere-Martino. J. Clin. Psychopharmacol. 21(2), 2001, 207-212.

4. Curran M.P and Perry C M. Spotlight on Amisulpride in Schizophrenia.

CNS Drugs 16(1), 2002, 207-211.

5. Geddes.J Freemantle.N Harrison.P andBebbington.P. BMJ. 32(1), 2000,

1371-6.

6. Stanniland.C and Taylor.D Tolerability of Atypical Antipsychotics.

Drug Safety 21(2),2000,195-214.

7. Isbister, K. Geoffrey.M FACEM, Balit.R Corrine.D. Macleod and

Duffull.B Stephen.B. Journal of Clinical Psychopharmacology.
30(4)2010,391-395.

8. Noble.S and P. Benfield.P CNS Drugs 12(2),1999, 471–483.

9. Hamon-Vilcot.B Chaufour.S DeschampsC,Canal.M, Zieleniuk.I,Ahtoy.I,

Chretien.I,Rosenzweig.P, Nasr.A and Piette.F, European Journal of Clinical
Pharmacology.54(5),1998,405-409.
Chapter 1 Introduction
 9

10. Rosenzweig.P ,Canal.M, Patat.A,Bergougnan.L, Zieleniuk.I and

Bianchetti.L,HumanPsychopharmacology:ClinicalandExperimental.17(1),200
2, 1-13.

11. Canal,M.MacMahon,J.wan.KandC.Dubruc.EuropeanNeuropsychopharmacol
ogy.10(2),2000, 330-335.

12. Nirogi.R ,Bhyrapuneni.G, Kandikere.V,Mudigonda.K,Ajjala.D. Suraneni.R

and Mukkanti.K Biomed Chromatogr. 22(9),2008, 1424-33.

13. Kratzsch.C.,FT.Peters.FT.,Kraemer.T., Weber.AA andMaurer.HH , Journal of

mass spectrometry.38(3), 2003, 283-295.

14. Gschwend.MH,Arnold.P, Ring.J and Martin.M Journal of Chromatography

B. 831(1-2), 2006, 132-139.

15. Kirchherr.H and Kuhn-Velten.WN. J Chromatogr B Analyt Technol Biomed

Life Sci. 843(1), 2006, 100-13.

16. Couchman L, Morgan PE, Flanagan RJ. Biomed Chromatogr. 32(5) 2010,
624 – 7.

17. Kratzsch C, Peters FT, Kraemer T, Weber AA, Maurer HH .J Mass Spectrom.
38(3), 2003, 283-295.

18. Zou.S, Wen.Y and Lin.Q, Biomed Chromatogr 26(6), 2009, 483-486.

19. Frahnert.C,Rao.ML,Grasmader.K.J Chromatogr B Analyt Technol Biomed

Life Sci.794(1), 2003, 35-47.
20. Chiba.R, Ogasawara.A, Kubo.T, Yamazaki.H.Umino.M and Ishizuka.Y

Chapter 1 Introduction
 10

. Anal Sci. 19(5),2003, 785-793.

21. Pehourcq.F,Ouariki.S and Segaud.. J Chromatogr B Analyt Technol Biomed

Life Sci. 789(1),2003, 101-105.

22. Sachse,S. Hartter, H. Weigmann and C. Hiemke. J.Chromatogr B Analyt

Technol Biomed Life Sci. 784(2), 2003, 405-410.

23. Jitsufuchi,K. Kudo,H. Tokunaga and T. Imamura. J Chromatogr B Biomed

Sci Appl. 690(1-2), 1997, 153-161.

24. Malavasi.B,Locatelli.M.,Ripamonti.M and Ascalone.M. J.Chromatogr B

Biomed Appl. 676(1), 1996,107-115.

25. Kamizono.N,Inotsume.S, Fukushim and Nakano.M,.Bioi Pharm Bull. Nov

16(3), 1993, 121-124.

26. Moulin.A,Truffer.D, Rauch.C,Desanti.M., Istin,JM. Grognet and Dufour.A.,

Eur J Drug Metab Pharmacokinet.Spec3,1991, 507-512.

27. DeJong.AP.,Wittebrood.AJ,.DuChatinier.WM and Bron.J. J. Chromatogr. 419

Aug,7.1987,233-242.

28. .Nishihara,K ,Kohda.Y,andTamura.Z.Chern Pharm Bull (Tokyo). 11(4),1983,

144-146.

29. Bohbot.M.,Doare.L, and Diquet.B.. J Chromatogr. 416(2),1987, 414-422.

30. Bressolle.F and Bres.J .J Chromatogr. 341(2),1985, 391-400.

Chapter 1 Introduction
 11

31. Mokrim,C. Brunet,M. Cazin, B. Gressier, M.Luyckx,T. Dine,H. Robert and

JC.Cazin . Clin Pharmacol. 15(1), 1993, 41-48.

32. Ascalone.V , Ripamonti.M, and Malavasi.B. J. Chromatogr B Biomed Appl.

676(1),1996, 95-105.

33. Das.A,Bhaumik.U.,Chakrabarty.US.,Sarkar.AK.,Ghosh,A.Bose.B.,Chatterjee.
B and Pal.TK. Arzneimittelforschung. 59(4),2009,166-170.

34. Illia.V and Nona.N Chromatographia.B 73(6),2001, 67-74.

35. Shams M, Hiemke C, Härtter S. Therapeutic drug monitoring of the

antidepressant mirtazapine and its N-demethylated metabolite in human
serum. Ther Drug Monit. 26(1), 2004, 78-84.

36. Skibinski.R ,Komsta.T, Hopkata.H and Suchodolska.I Anal Chim Acta.

590(2), 2007, 195-202.

37. Sibel Suzen, B. Tolga Demircigil, Erdem Buyukbingol and Síbel A. ozkan
New J. Chem. 27(4),2003, 1007-1011.

38. Guidance for industry: bioanalytical method validation, U.S. Department of

Health and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research(CDER), Center for Biologics Evaluation and
Research (CBER), May 2001.

39. Guidance for industry: Food- effect bio availability and Fed Bio equivalence
studies. U.S.Department of Health and Human services Food and Drug
Administration Centre for Drug Evaluation and research (CDER) December
2002.

Chapter 1 Introduction
 12

40.Guidance for industry Bio availability and Fed Bio equivalence Studies for
Orally Administered Drug Products-General considerations U.S.Department
of Health and Human services Food and Drug Administration Centre for
Drug Evaluation and research (CDER) March 2003.

Chapter- 5
5.7 References

1. http://en.wikipedia.org/wiki/Rifaximin#cite_note-3

2. Zhang X, Duan J, Li K, Zhou L, Zhai S. J.Chromatogr B Analyt Technol

Biomed Life Sci, 850(1-2), 2007,348-355.

3. Rao RN, Shinde DD and Agawane SB. Biomed Chromatogr. 23(6) ,2009,563-

567.

4. Rao RN, Vali RM and Shinde DD Biomed Chromatogr. 23(11) ,2009,-1145-

50

5. Corti P, Savini L, Celesti L, Ceramelli G, Montecchi L. Pharm Acta

Helv. ,67(3), 1992,76-79.

6. Venturini I, Ferrieri A, Farina F, Cosenza F, Avallone R, Corsi L, Baraldi M

and Zeneroli ML. Drugs Exp Clin Res. 31(4), 2005, 161-168.

7. Descombe JJ, Dubourg D, Picard M, Palazzini E. Int J Clin Pharmacol

Res. 14(2),1994, 51-56.

8. Guidance for industry: bioanalytical method validation, U.S. Department of

Health and Human Services, Food and Drug Administration, Center for Drug

Chapter 1 Introduction
 13

Evaluation and Research(CDER), Center for Biologics Evaluation and

Research (CBER), May 2001.

9. Guidance for industry: Food- effect bio availability and Fed Bio equivalence

studies. U.S.Department of Health and Human services Food and Drug

Administration Centre for Drug Evaluation and research (CDER) December

2002.

10. Guidance for industry Bio availability and Fed Bio equivalence Studies for

Orally Administered Drug Products-General considerations U.S.Department

of Health and Human services Food and Drug Administration Centre for Drug

Evaluation and research (CDER) March 2003.

Chapter- 6

6.7 References

1. http://en.wikipedia.org/wiki/Esomeprazole.

2. Martens-Lobenhoffer J, Reiche I,Troger U, Monkemuller K, Malfertheiner P,

and Bode Boger SM Chromatogr B Analyt Technol Biomed Life Sci,857(2),

2007, 301-307.

3. Hultman.Ia, Stenhoff.H, and Liljeblad. M.J Chromatogr B Analyt Technol

Biomed Life Sci,848(2), 2007, 317-322.

4. Stenhoff.H, Blomqvist.A, and Lagerstrom.P.O.J Chromatogr B Biomed Sci

Appl,734(2), 1999, 191-201.

Chapter 1 Introduction
 14

5. Zhou G, Tan ZR, Zhang W, Ou-Yang DS, Chen Y, Guo D, Liu YZ, Fan L,

and Deng HW. Acta Pharmacol Sin, 30(9), 2009, 1330-1336.

6. Orlando.R.M, and Bonato P.S. J.Chromatogr B Analyt Technol Biomed Life

Sci , 795(2), 2003, 227-235.

7. Cairns AM, Chiou RH and Rogers JD, Demetriades JL. Enantio.J Chromatogr

B Biomed Appl; 666(2), 1995, 323-328.

8. Rhim S.Y , Park J.H, Park Y.S, Lee M.H, Hwang K.G, Kim Y.S, Shaw L.M,

Lee Y.S and Kang J.S.. Int J Clin Pharmacol Ther, 47(1), 2009, 23-29.

9. Baldwin RM,Ohisson S, Pedersen RS, Mwinvi J, Ingelman-Sundberg

M,Eliasson E and Bertilsson L. Br J Clin Pharmacol ,65(5), 2009, 767-774.

10. Hassan-Alin M, Andersson T, Niazi M and Rohss KA Eur J Clin

Pharmacol;60(11), 2005, 779-784.

11. Hassan-Alin M, Andersson T, Bredberg E and Rohss K. Eur J Clin

Pharmacol,56(9-10), 2000, 665-670.

12. Tonini M, Vigneri S, Savarino V and Scarpignato C. Review Erratum in: Dig

Liver Dis ,34(1), 2002, 87-92.

13. Bhoir SI,Bhoir IC, Bhagwat AM and Sundaresan M.J Chromatogr B Analyt

Technol Biomed Sci Appl,757(1), 2001, 39-47.

14. Tamminga WJ, Wemer J, Oosterhuis B,Brakenhoff JP, Gerrits MG, de Zeeuw

RA, deLeijLF and Jonkman JH .Eur J Clin Pharmacol,57(2), 2001, 143-146.

15. OIsson J,Stegander F, Marlin N, Wan H and Blomberg LG. J Chromatogr

A,1129(2), 2006, 291-295.

Chapter 1 Introduction
 15

16. Toribio L, Alonso C, del Nozal MJ, Bernal JL and Martin MT. J Chromatigr

A,1137(1), 2006, 30-35.

17. Kanazawa H, Okada A, Higaki M, Yokota H, Mashige F and Nakahara K.. J

Pharm Biomed Anal,30(6), 2003, 1817-1824.

18. Redondo J, Capdevila A and Latorre I.Chirality,22(5), 2010, 472-478.

19. Li XQ, Weidolf L, Simonsson R and Andersson TB. J Pharmacol Exp

Ther,315(2), 2005, 777-787.

20. Mihara K, Svensson US, Tybring G, Hai TN, Bertilsson L.A and Shton M,.

Clin Pharmacol,13, 1999, 671-675.

21. Andersson S, Nelander H and Ohlen K. Chirality ;19(9), 2007, 706-715.

22. Guidance for industry: bioanalytical method validation, U.S. Department of

Health and Human Services, Food and Drug Administration, Center for Drug

Evaluation and Research (CDER), Center for Biologics Evaluation and

Research (CBER), May 2001.

23. Guidance for industry: Food- effect bio availability and Fed Bio equivalence

studies. U.S.Department of Health and Human services Food and Drug

Administration Centre for Drug Evaluation and research (CDER) December

2002.

24. Guidance for industry Bio availability and Fed Bio equivalence Studies for

Orally Administered Drug Products-General considerations U.S.Department

Chapter 1 Introduction
 16

of Health and Human services Food and Drug Administration Centre for Drug

Evaluation and research (CDER) March 2003.

Chapter 1 Introduction