陳桂恒

客座教授

• Ph.D., Pharmaceutics, University of Minnesota, Minneapolis, Minnesota, USA Dissertation Advisor:  Kenneth W. Miller, Ph.D.
• M.S., Pharmaceutical Sciences, North Dakota State University, Fargo, North Dakota, USA Dissertation Advisor:  Lloyd E. Matheson, Jr., Ph.D.
• B.S. Pharmacy, Kaohsiung Medical College, Kaohsiung, Taiwan, Rep. of China

tel: 02-29393091#89094
e-mail: kchan@globoasia.com

• Drug Product Life Cycle Management and Drug Development Process
• Regulatory Sciences on Drug Development and Approval
• Rational Design of Controlled Release Dosage Forms
• Physiological Factors Affecting GI Motility and Transit of Oral Formulations
• Application of Microcomputer in Pharmacokinetics
• Noncompartmental Pharmacokinetic Data Analysis Statistical Analysis on Bioequivalence studies

• 科技法律與智財權研討
• 生技藥物法規與智財權管理研討

• 1984 年起在 University of Minnesota 擔任兼任教職
• 1994 年起在University of Maryland 擔任兼任教授，先後指導過十多名碩博士班學生。

此一產官學的豐富經驗，讓他成為國際生技製藥發展的最佳技術經理人。

• 目前擔任衛生署藥政處及醫藥品查驗中心的顧問，對國內醫藥管理的法規及制度化有卓著的貢獻。
• 由於目前每年均有二至三個月時間滯台，因其一向對教學具有高度熱誠，凱然答應抽空開授其專長課程，相信對本所及本校博、碩士班同學將擴展其對國際生技製藥領域的宏觀視野。陳教授也於本學期通過本校兼任教授的三級三審。

1995以藥物在人體吸收的研究榮獲美國藥學科學家協會(Association of Pharmaceutical Scientists (AAPS)) Fellow榮銜。現在擔任president of American Chinese Pharmaceutical Association (ACPA)。

1. 1997 年創設GloboMax公司，在2003年成長至擁有一百人雇員時讓渡給ICON, plc。，成為美國華人生技公司創業的成功模式。
2. GloboMax的成功創業案例之後，成立GloboAsia公司，利用本身橫跨產官學之豐富經驗，協助亞洲之生技製藥公司，提供申請FDA臨床試驗的諮詢及安排，在專利的技術轉移及臨床試驗安排，能在國際市場中異軍突起，創造應有的價值。最近多家國內生技公司得到其協助，最近的成功案例為讓國內一家未上市的小藥廠，在三年多投入不到一億台幣的研發經費後，日前已獲美國大藥廠正式簽約取得授權，讓台灣成為原創性新藥的輸出國，此一成功案例並獲得本年台北生技獎的表揚。

July 1998          President and CEO
- Present           GloboAsia LLC, Rockville, Maryland

March 2004               President and CEO
- Present           Revico Inc., Rockville, Maryland

July, 1997         Co-Founder and Senior Vice President and VP RA/QA Compliance
- Sept. 2003            GloboMax LLC, Hanover, Maryland (GloboMax acquired by ICON, plc in 2003)

July 1997          Adjunct Professor of Pharmaceutical Sciences
- Present           School of Pharmacy, University of Maryland at Baltimore, Baltimore, Maryland

July 1996 – Present       Consultant to numerous (more than 80) multi-national, startup, medium size and national, Asian pharmaceutical companies, biotech companies, device companies, research centers, regulatory agencies and universities  

August 1999                  Advisor, Bureau of Pharmaceutical Affairs, Department of Health,
- Present                       Executive Yuan, Taiwan, R.O.C.

Dec 2003 – Present       Board of Director, Monte-Jade Washington DC Chapter

Jan 2005 – Present        President, American Chinese Pharmaceutical Association

May 2000 - 2006            Regulatory Advisor, Center for Drug Evaluation (CDE), Taiwan, ROC
Scientific Advisor, Pharmaceutical Industry Technology Development Center (PITDC), Taiwan, ROC

July 1998          Board of Director, Unitech Pharmaceuticals, Inc., Michigan
- Present           Scientific Advisory Board, Pennsylvania BioLab, Inc. (PaBL), King of Prussia, PA

July 1996                      Scientific Advisor, National Laboratories of Foods and Drugs, Department of
- July 2004                    Health, Executive Yuan, Taiwan, R.O.C.

April 1998         Regulatory Advisor, BioTech and Pharmaceuticals Promotional Group, Ministry of – March, 2000                 Economic Affairs, Taiwan, R.O.C.  

July,1997          Research Professor of Pharmaceutical Sciences
- July 1998        School of Pharmacy, University of Maryland at Baltimore, Baltimore, Maryland

October, 1996           Assistant Director
- July 1997            Pharmacokinetics-Biopharmaceutics Laboratory
                   School of Pharmacy, University of Maryland at Baltimore, Baltimore, Maryland

April, 1995               Director
- October,1996              Division of Bioequivalence, Office of Generic Drugs
                   Food and Drug Administration, Rockville, Maryland

1984 - Present           Adjunct Professor/Associate Professor / Assistant Professor
                   College of Pharmacy, University of Minnesota, Minneapolis, Minnesota

1980- 1995        Manager / Section Head / Group Leader / Sr. Research Scientist / Sr. Scientist
                  Research Support and Pharmacokinetics / Bioanalytics and Pharmacokinetics /                   Clinical Pharmacokinetics and Disposition / Drug metabolism
                  Ciba-Geigy Corporation (now Novartis Pharmaceuticals Corporation)
                  Ardsley, New York and Summit, New Jersey

1976 - 1979               Assistant I / Teaching Associate I / Teaching Associate II
College of Pharmacy, University of Minnesota, Minneapolis, Minnesota

1975 - 1976               Research Assistant
Clinical Pharmacokinetic Laboratory, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota

1974 - 1975               Staff Pharmacist
Lutheran Hospital, Moline, Illinois

1972 - 1974               Research Assistant
State Toxicology Laboratory, College of Pharmacy, North Dakota State University, Pharmacokinetic Laboratory, VA Hospital, Fargo, North Dakota

1. KW Miller, KKH Chan, HG McCoy et al., Cephalothin Kinetics: Before, During and After Cardiopulmonary Bypass Surgery.  Clin. Pharmacol. Ther., 26: 54, 1979
2. KW Miller, HG McCoy, KKH Chan et al.,  Alternation of Cefazolin Disposition by Cardiopulmonary Bypass Surgery.  Clin. Pharmacol. Ther., 27: 550, 1980
3. KKH Chan and M Gibaldi,  Estimation of Statistical Moments and Steady-State Volume of Distribution for Drug Given by Intravenous Infusion.  J. Pharmacokin. Biopharm., 10: 551, 1982
4. KKH Chan, K Wnuck and K Vyas,  A Rapid and Sensitive Method For the Determination of Diclofenac Sodium in Plasma by High Performance Liquid Chromatography.  Anal. Lett., 15 (B21&22): 1649, 1982
5. KKH Chan and KW Miller,  Nonlinear Regression Approach for Determining Whether Absorption And Elimination Rate Constants Are Equal in the One-Compartment Open Model With First-Order Process.  J. Pharm. Sci., 72: 574, 1983
6. KKH Chan and K Wnuck,  Microcomputer Based Pharmacokinetic Programs For Calculating Absorption Rate.  Comp. Prog. Biomed., 16: 27, 1983
7. KKH Chan and M Gibaldi,  Evaluating Drug Absorption After Oral Administration.  Some Problems and Some Solutions.  Eur. J. Clin. Pharmacol., 26: 255, 1984
8. KKH Chan and K Wnuck,  Microcomputer Based Programs For Plotting and Simulating Pharmacokinetic Data.  The Proceedings of the 1984 Summer Computer Simulation Conference, 2: 754, 1984
9. KKH Chan and M Gibaldi,  Assessment of Drug Absorption After Oral Administration.       J. Pharm. Sci., 74: 388, 1985
10. KS Hui, SS Hui and K Chan, Separation of Enkephalins From Their Metabolites and Precursor By A Single Pump Gradient HPLC.  J. Chromatogr., 325: 467, 1985
11. E Redalieu, KKH Chan, V Tipnis et al., Kinetics of  Hydrochlorothiazide Absorption in Man. J. Pharm. Sci., 74: 765, 1985
12. KKH Chan, RJ Sawchuk, TA Thompson et al.,  Bioequivalence of  Carbamazepine Chewable and Conventional Tablets.  Single Dose and  Steady-State Studies.  J. Pharm. Sci., 74: 866, 1985
13. KS Hui, SS Hui and K Chan,  BIOGRAD: A Software Package Controlling A Single Pump Gradient System For Liquid Chromatography.  Life Sci., 36: I, June 24, 1985
14. W Kreis, F Chadhuri, K Chan et al.,   Pharmacokinetics of Low-Dose ARA-C Given By Continuous Intravenous Infusion Over Twenty-one Days.  Can. Res., 45: 6498, 1985
15. HL Liauw, E Ku, KD Brandt, KKH Chan et al.,  Effect of Voltaren on  Arachidonic Acid Metabolism in Arthritis Patients.  The Proceedings on Basis for Variability in Response, Satellite Meeting NSAID's, Agents and Actions, Supplement 1985
16. KKH Chan and K Vyas,  Determination of diclofenac sodium in synovial fluid by high performance liquid chromatography, Anal. Lett., 18(B20):2507, 1985
17. L Raid, RJ Sawchuk, WE Wagner and KKH Chan,  Simultaneous First- and Zero-Order Absorption of Carbamazepine Tablets in Humans.  J. Pharm. Sci., 75: 897, 1986
18. KKH Chan, K Wnuck and K Vyas et al., Determination of CGS 13080, A New Thromboxane Synthetase Inhibitor, in Plasma and Urine by HPLC and Its Application to a Pharmacokinetic Study.  The Proceedings of the Third Annual International Symposium on Sample Preparation and Isolation Using Bonded Silicas. 1986, pp. 75-92
19. KKH Chan, K Vyas and KD Brandt,  In-Vitro Protein Binding of Diclofenac Sodium in Plasma and Synovial Fluid.  J. Pharm. Sci., 76: 105, 1987
20. KKH Chan, F Langenbucher and M Gibaldi, Determination of In-Vivo Drug Release By Numerical Deconvolution.  J. Pharm. Sci., 76: 446, 1987
21. KKH Chan, K Wnuck and CL Bell,  Microcomputer Based Programs to Calculating Mean and Variance Residence Time by the Method of Prospective Areas.  Comp. Meth. Prog. Biomed., 25: 23, 1987
22. W Kreis, KKH Chan, DR Budman et al.,  Effect of Tetrahydrouridine (THU) on the Clinical Pharmacology of 1-b-D-Arabinofuranosylcytosine (ARA-C) When Both Drugs Are Coinfused Over Three Hours.  Can. Res., 48: 1337, 1988
23. W Kreis, C Rottach, DB Budman, K Chan et al.,  Pharmacokinetics and Phase I Evaluation of Esorubicin (4'Deoxydoxorubicin) by Continuous Infusion Over Forty-Eight Hours in Patients with Leukemia.  Can. Res., 48: 5580, 1988
24. P Mojaverian, K Chan, A Desai, and V John,  Gastrointestinal Transit of a Solid Indigestible Capsule as Measured by Radiotelemetry and Dual Gamma Scintigraphy.  Pharm. Res. 6: 719, 1989
25. KKH Chan and M Gibaldi,  Effect of First-Pass Metabolism on Metabolite Mean Residence Time Determination After Oral Administration of Parent Drug. Pharm. Res. 7:59, 1990
26. KKH Chan, P Mojaverian, V John et al.,  Application of Radiotelemetric Technique in Evaluating Diclofenac Sodium Absorption After Oral Administration of Buffered Aqueous Solution, Enteric-Coated Tablet and Slow-Released Tablet to Healthy Volunteers.  Pharm. Res. 7:1026, 1990
27. K Chan, H Ross, A Piraino, and V John,  Pharmacokinetics of a Single Dose of Transdermal Nicotine in Healthy Smokers.  J. Controlled Rel. 14:145-151, 1990
28. W Kreis, DR Budman, K Chan et al.,  Therapy of Refractory/Relapsed1 Acute Leukemia with Cytosine Arabinoside Plus Tetrahydrouridine (An Inhibitor of Cytidine Deaminase) - A Pilot Study.  Leukemia 5:991-998, 1991
29. K Chan, H Ross, A Piraino et al., Single and Multiple Daily Transdermal Dose Pharmacokinetics of Nicotine in Healthy Adult Smokers, Pharm. Res., 3:385-388, 1991
30. LE Riad, KKH Chan and RJ Sawchuk, Determination of the Relative Formation and Elimination Clearance of Two Major Carbamazepine Metabolites in Humans: A Comparison Between Traditional and Pooled Sample Analysis.  Pharm. Res. 8:541-543, 1991
31. NL Benowitz, K Chan, C Denaro, P Jocob,  Stable Isotope Method For Studying Transdermal Drug Absorption: The Nicotine Patch.  Clin. Pharmacol. Ther. 50:286-293, 1991
32. LE DeAngelis, W Kreis, K Chan, D Dantis, S. Akerman, Pharmacodynamics of ARA-C and ARA-U in Plasma and CSF After High-Dose Administration.  Cancer Chemother. Pharmacol. 29:173-177, 1992
33. J Cassidy, B Berner, K Chan and V John, Human Trans-Buccal Absorption of Diclofenac Sodium From a Prototype Hydrogel Delivery Device, Pharm. Res. 10:126-129, 1993
34. E Redalieu, JM Coleman, K Chan, J Seaman, PH Degen, G Flesch, A Brox, and G Batiste, Urinary Excretion of Aminohydroxypropylidene Bisphosphonate (APD) in Cancer Patients After Single Intravenous Infusion, J. Pharm. Sci., 82:665-667, 1993
35. LE Riad, KKH Chan and RJ Sawchuk, Transient Steady-State Analysis: Application in the Determination of the Relative Formation and Elimination Clearances of Two Major Carbamazepine Metabolites in Humans, Pharm. Res. 10:1090-1092, 1993
36. C Alioth, RA Blum, DT D'Andrea, GM Kochak, L Teng, BA Ziehmer, JJ Schentag and KKH Chan, Application of Dual Radiotelemetric Technique in Studying Drug-Drug Interaction Between Diclofenac Sodium and Ranitidine HCL in Volunteers, Pharm.  Res. 10:1688-1692, 1993
37. KKH Chan, Pharmacoscintigraphy: Techniques for Studying Drug Release and Absorption in Humans, (Invited review article), J. Food & Drug Analysis, 3:235-244, 1993
38. KKH Chan, A Buch, RD Glazer, VA John and WH Barr, Site Differential Gastrointestinal Absorption of Benazepril Hydrochloride in Healthy Volunteers, Pharm. Res. 11: 432-437, 1994
39. RL Oberle, H Das, SL Wong, KKH Chan and RJ Sawchuk, Pharmacokinetics and Metabolism of Diclofenac Sodium in Yucatan Miniature Pigs,  Pharm. Res. 11:698-703, 1994
40. JX Sun, A Cipriano, K Chan, M Klibaner and VA John, Effect of Food on the Relative Bioavailability of a Hypolipidemic Agent (CGP 43371) in Healthy Subjects, J. Pharm. Sci. 83:264-266, 1994
41. JX Sun, JM Morgan, JC Joshi, K Chan, VA John and WR Good, Application of a Stable Isotope Technique in Study the Bioequivalency of Two Transdermal Nitroglycerin Systems, Am. J. Therapeutics, 1:15-21, 1994
42. WK Cheung, L Brunner, F Honc, S Schoenfeld, J Seaman, VA John and K  Chan, Pharmacokinetics of Pamidronate Disodium in Cancer Patients After a Single Intravenous Infusion of 30-, 60-, or 90-mg Dose Over 4 and 24 Hours, Am. J. Therapeutics, 1:1-8, 1994
43. KKH Chan, Application of Stable Isotope Method in Study Bioavailability and Bioequivalence of Highly Variable Drugs and Formulations, J. of Food and Drug Analysis, 2:155-160, 1994
44. LE Riad, KKH Chan, JA Maloney and RJ Sawchuk, Enzyme Induction of Carbamazepine: I. Effect of Dosing Frequency on the Extent of Induction, Submitted to Pharm. Res., 1994
45. JX Sun, A Cipriano, K Chan and VA John, Pharmacokinetic Interaction Study Between Benazepril and Amlodipine in Healthy Subjects, Eur. J. Clin. Pharmacol., 47:285-289, 1994
46. WK Cheung, F Honc, S Schoenfeld, R Knight, J Seaman, AT Bowen, VA John, E Redalieu and K Chan, A Single-Dose Bioavailability of Pamidronate Disodium After Oral Administration as Encapsulated Enteric-Coated Pellets, Enteric-Coated Tablets and a Solution to Patients with Postmenopausal Osteoprosis, Am. J. Therapeutics, 1:221-227, 1994
47. WF Elmquist, KKH Chan and RJ Sawchuk, Transynovial Distribution:  Synovial Mean Transit Time of Diclofenac and Other Nonsteroidal Antiinflammatory Drugs. Pharm. Res. 11:1689-1697, 1994
48. HC Hsu, HL Lu, TC Chi and KKH Chan, A Comparative Study of Confidence Region Methods in Determination of Bioequivalence Between Two Formulations, Drug Inf. Journal, 29: 1021-1028, 1995
49. LE Riad, RJ Sawchuk, MM McAlary, VA John and KKH Chan, Effect of Food on the Multiple Peak Behavior After a Single Oral Dose of Diclofenac Sodium Slow Release Tablet in Humans, Am. J. Therapeutics, 2:1-6, 1995
50. MJ Combs, K Chan, RU Mulder, C Alioth, BY Croft, CD Teates and RW McCallum, Effects of Food on Gastrointestinal Transit in Humans of Two Different Sizes of Hydrogel Beads Using Dual-Isotopic Gamma Scintigraphy and Neutron Activation Techniques, Submitted to J. Control Rel., 1994
51. HC Hsu, HL Lu and KKH Chan, A Novel Multivariate Approach in Estimating the Degree of Similarity in Bioavailability Between Two Pharmaceutical Products, J. Pharm. Sci., 84:768-772, 1995
52. RJ Sawchuk, JA Maloney, LL Cartier, RJ Rackley, KKH Chan and HSL Lau, Analysis of Diclofenac and Four of Its Metabolites in Human Urine by HPLC, Pharm. Res., 12:756-762, 1995
53. RC Li, SL Wong and KKH Chan, Microcomputer Based Programs for Pharmacokinetic Simulations, Am. J. Pharm. Edu., 59:143-147, 1995
54. WK Cheung, F Kianifard, A Wong, J Mathieu, T Cook, V John, E Redalieu and K Chan, Intra- and Inter-Subject Variabilities of CGP 33101 After Replicate Single Oral Doses of Two 200-mg Tablets and 400-mg Suspension, Pharm. Res., 12:1878-1882, 1995
55. W Kreis, K Chan, DR Budman, SL Allen, D Fusco, A Mittelman, J Freeman, K Hock, S Akerman, A Calabro, C Puccio and J Spigelman, Clinical Pharmacokinetics of Amonafide (NSC 308847) in 62 Patients, Cancer Investigation, 14:320-327, 1996
56. JX Sun, B Walter, EP Sandefer, RC Page, GA Digenis, UY Ryo, A Cipriano, WM Maniara, ML Powell and K Chan, Explaining Vairable Absorption of a Hypolidemic Agent (CGP 43371) in Healthy Subjects by Gamma Scintigraphy and Pharmacokinetics, J. Clin. Pharmacol., 36:230-237, 1996
57. R Patnaik, LJ Lesko, K Chan, RL Williams, Bioequivalence of Generic Drugs: An American Point of View.  Eur. J. Drug Metab. Pharmacokinetics, 21:159-164, 1996.
    
58.   RC Li, SL Wong and KKH Chan, Expanded Version of "PKSIM" for Pharmacokinetic Simulation of Both Metabolite and Parent Drug, In Press, Am. J. Therapeutics, 4:16-22 1997
59. GA Van Buskirk,  MA Gonzalez, VP Shah, S Barnhardt, C Barrett, S Berge, G Cleary, K Chan, G Flynn, T Foster, R Gale, R Garrison, S Gochnour, A Gotto, S Govil, VA Gray, J Hammar, S Harder, C Hoiberg, A Hussain, C Karp, H Llanos, J Mantelle, P Noonan, D Swanson, and H Zerbe, Scale-up of Adhesive Transdermal Drug Delivery Systems, Pharmaceutical Research, 14, 7:848-852, 1997, European J. Pharmacetuics and Biopharm., 44:327-331, 1997
60. K Chan, SY Lee, C Cheng, PL Shih, Assessing the Potential Bioequivalence Requirement for Oral Immediate Release Dosage Form:  Post Approval Changes for Cardiovascular Drugs, Journal of Food and Drug Analysis, 6:537-552, 1998
61. M Meyer, K Chan, S Bolton, Generic Warfarin: Implications for Patient Care – Another View, Pharmacotherapy 18:884-886, 1998
62. JS Lill, T O’Sullivan, LA Bauer, JH Horn, R Carithers, Jr., DE Strandness, H Lau, K Chan and K Thakker, Pharmacokinetics of Diclofenac Sodium in Chronic Active Hepatitis and Alcohol Cirrhosis, J. Clin. Pharmacol., 40:1-8, 2000.
63. FC Chang, HD Chern, K Chan, From Chinese Herbal Medicine to Botanical Drug Regulatory Requirements from Taiwan to a United States IND Submission, Drug Info. Journal, S37(4), 49, 2003.