Jack S. Liu

**** * ******** **, ***

Chicago, IL 60660

Mobile: 805-***-****

E-mail: acciti@r.postjobfree.com

OBJECTIVE

Looking for a position of drug safety evaluation, i.e., safety physician or medical reviewer (ICSR).

SUMMARY STATEMENT

Self-motivated, persistent, efficient and reliable drug safety physician with 8-year-experience working in

pharmaceutical and biotech companies conducting single case (ICSR) medical review, signal detection,

aggregate safety analysis and more than 10-years-experience of clinical services of surgical pathology

and oncology as well as biomedical research. Proficient in English and Mandarin-Chinese with pleasant

personalities and motivation of team work.

APPOINTMENT AND EMPLOYMENT HISTORY

Medical Director, Clinical Safety Evaluation, Global Pharmacovigilance and Medical Services, AbbVie,

North Chicago IL, 01/2013 – 10/2013.

Medical Director, Clinical Safety Evaluation,Global Pharmacovigilance and Medical Services, Abbott

Laboratory, North Chicago IL, 09/2009 - 12/2012.

• Conduct medical review of ICSRs of assigned compounds of Oncology, Metabolic, Neuroscience,

Cardiovascular, GI, Respiratory, Women's & Men's Health, Pain Management etc.

• Confirm the accuracy of coding relative to the Investigator’s reported event verbatim(s).

• Assess expectedness and triage SAE and Non-serious AE at event and case level.

• Provide sponsor’s causality and alternative etiology for expedited SAEs.

• Confirm search strategy for identifying similar events for expedited reports.

• Issue queries as needed for further clarification of the case.

• Benefit/risk assessment.

• Conduct safety surveillance to identify potential safety signals for pre-marketed products.

• Work in close collaboration with Safety Operations, initiate, and contribute to procedures for

optimization, identifying hidden/embedding adverse events and improving medical review process.

• Optimize and standardized expedited reporting of SAEs in clinical studies by successfully

building PT-library.

• Developed

- Guidance for physicians who perform causality assessment, alternative etiology and

company analysis;

- Clinical Safety Evaluation Physician Training Manual describing SAE case processing,

regulatory requirements, expectedness and causality assessment, expedited reporting for

clinical trial cases and SAEs in periodic regulatory submission (IND annual report and DSUR)

etc.

- Guidance on Periodic Aggregate Safety Analysis and Assessment Process for Proactive

Safety Surveillance and Signal Detection in Clinical Trials.

Global Safety Manager, Oncology, Dept. Safety Surveillance, Amgen Global Regulatory and Safety,

Amgen Biotech Inc., Thousand Oaks, California, 07/2005 - 08/2009.

• Conduct safety surveillance to identify potential safety signals for Amgen post and pre-marketed

products (Neupogen, Neulasta, Kepivance, Angiogenesis inhibitor (AMG 386, AMG 706), IGF Inhibitor

(AMG 479) and apoptotic promoters (AMG 951).

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• Conduct aggregated safety analyses of phase 1, 2 and 3 clinical trials and draft response to ad

hoc queries from FDA, EMEA and other global regulatory agencies and medical communications.

• Perform aggregate safety analysis of adverse event (AEs, SAEs and EOIs) quarterly or

periodically for Phase 1, 2 and 3 clinical trials.

• Support drafting initial version and updates to safety sections of ICF, CDS, DCSI and USPI.

Research Assistant Professor, Robert H Lurie Comprehensive Cancer Center, Feinberg School of

Medicine, Northwestern University, Chicago, Illinois directed by Professor Susan Cohn, 05/2001-07/2005.

• Conduct research on identification of angiogenesis inhibitors in human neuroblastoma

• Teach and mentor medical students and research fellows.

Research Fellow/Scientist, ENH Research Institute, Evanston Northwestern Healthcare, Northwestern

University, Evanston, Illinois directed by Professor Ann D Thor, 07/1996-05/2001.

• Conduct research on breast cancer on identifying prognosticators

• Manage and maintain laboratory routine activities.

Post Doctoral Fellow, Cell Imaging Facility, Department of Pathology, Medical School, State University

of Vermont, Burlington, Vermont, 07/1995-06/1996.

• Perform research on 3D reconstruction of cytometric images from normal breast, benign

hyperplasia, dysplasia, in situ carcinoma, invasive carcinoma to metastatic carcinoma.

Associate Professor, Department of Anatomic and Surgical Pathology, Medical School, University of

Beijing, Beijing, 05/1993-96/1995.

• Teach under and graduate medical students pathology and oncology.

• Clinical services of surgical pathology diagnosis and autopsies.

• Conduct research on cancer DNA cytometry.

MD candidate/Fellow Scientist, Institute of Pathology and Cytology, College of Medicine, Aachen

University of Technology, Germany (fellowship and fund granted by Alexander von Humboldt

Foundation), 05/1990-05/1993.

Attending Pathologist, Cancer Institute and Department of Oncology, First Clinical College, China

Medical University, Shenyang, 08/1988-04/1990.

• Clinical services of surgical pathology and oncology

• Conduct research on cancer and precancers DNA/Image cytometry

Fellow/Instructor, Department of Surgical and Anatomic Pathology, China Medical University, 03/1982-

94/1984.

• Clinical services of surgical pathologic diagnosis and autopsies

• Teach under graduate medical student laboratory theory and techniques.

Surgical Pathologist, Department of Surgical Pathology, Red Cross Hospital, Shenyang, 03/1984-

08/1987.

• Clinical services of surgical pathologic diagnosis and autopsies.

Resident, Department of General Surgery, Red Cross Hospital, Shenyang, 01/1978-02/1981.

• Clinical services in out patient surgical and ER department under supervision of senior surgeons

EDUCATION, ACADEMIC DEGREES AND CERTIFICATES

MD, Medical School, Aachen University of Technology, Germany, 1990-93.

Thesis on human cancer DNA cytometry and image analysis published by Verlag Shaker, Germany

(ISBN 3-86111-352-X, 1993) and graded as “magna cum laude, 1” which represents the best note that

can be obtained and the first class honors was proposed by reviewers additionally to the best note that

resulted in an award of a DNA Image Analysis System from Alexander von Humboldt Foundation for

continuous research. Doctoral work was supervised by Professor Alfred Boecking who is one of the

world leading researchers in the field of cancer DNA image cytometry.

MD/PhD, MS, First Clinical College, China Medical University, Shenyang, China, past all exams for all

courses and trainings required, 1985-90. Thesis on Tumor Pathology and Immunohistochemistry; seven

papers related to the degree work were published in 1987-91 (Publication List 30-37).

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Board Certificate for Surgical Pathologist and Oncologist, issued by China Medical University,

Shenyang, China, 1982.

Board Certificate for General Surgeon issued by Medical Bureau of Shenyang, China, 1981.

Bachelor of General Medicine, Faculty of General Medicine, China Medical University, Shenyang,

China, 1978.

PROFESSIONAL TRAININGS

• Advanced MedDRA Coding, San Diego, CA11/16/2005.

• Safety Signal Detection Training Module 1-5, Thousand Oaks, CA, 11/20/2008.

• Pre-marketing Clinical Safety and Pharmacovigilance, DIA Head quarter, Horsham PA, 11/15-

16/2010.

Basic Statistical Concepts as they apply to drug development. Abbott Park N Chicago.

•

6/24/2011.

Toxicology in drug development. Abbott Park N Chicago. 8/10 - 9/27, 2011.

•

- Part 1. General aspects of preclinical safety

- Part 2. Special topic in preclinical safety

- Part 3. Toxicology adverse event reporting

Essentials of Pharmacoepidemiology for Drug Safety Assessments. Abbott Park N Chicago.

•

6/8 - 8/3, 2011.

- Topic 1. Epidemiology and Pharmocoepidemiology

- Topic 2. Causality Assessment

- Topic 3. Epidemiology Study

- Topic 4. Registry

- Topic 5. Literature sources

Suicidality Assessment in Clinical Development and Pharmacovigilance. Abbott Park N

•

Chicago. 10/3/2011.

Pharmacogenetics: Considerations in safety and effectiveness of drug

•

therapy.02//6/2012.

Clinical Pharmacology studies:

•

- Introduction to 1st-in-human clinical trials

- Safety monitoring in Phase 1 trials. 02/26/2012.

Normal healthy volunteer issue in the phase I unit. 03/06/2012

•

Clinical pharmacology studies other than first in human, 04/16/2012

•

Regulatory focus on drug safety, 05/15/2012

•

- Investigational new drug (IND) basis

- New drug application (NDA) basis

Immune Mediated Reactions and the Safety of Therapeutic Proteins. 6/20/2012

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Project Management - Creative approach to managing projects and effective finishing

•

what matters most. 7/17/2012

Leadership development: Open Communication - Communicating sensitive information,

•

7/31/2012

CLINICAL EXPERIENCE

• Clinical services as an associate professor of pathology at the Dept of Anatomic and Surgical

Pathology, Medical School, University of Beijing, 1993-95.

• Clinical services as an attending pathologist at the Dept of Oncology and Laboratory of Gastric

and Pulmonary Cancer, 1st Clinical College, China Medical University, Shenyang, 1988-90.

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• Clinical services as a surgical pathologist at the Dept of Surgical Pathology, Red Cross Hospital,

Shenyang, 1984-87.

• Clinical services of surgical pathology as a re-trainee at the dept of surgical pathology and

oncology, 1st Clinical College, China Medical University, 1982-83.

• Clinical serves as resident and general surgeon at the Dept of Surgery, Red Cross Hospital,

Shenyang, 1978-81.

RESEARCH EXPERIENCE

• Identification/characterization of angiogenesis inhibitors in human neuroblastoma, 2001-2005.

• Carcinogenesis in transgenic mice, 1999-01.

• Prognostic significance of cell turnover (apoptosis and proliferation)and gene markers in breast

cancer, 1996-01.

• 3D-reconstruction using confocal laser scanning microscope (CLSM) and its application in

clinical pathologic diagnosis for borderline lesions and tumors, 1995-96.

• DNA-aneuploidy as a marker for prospective malignancy in cancer and precancers, 1993-95.

• DNA cytometric study on benign, dysplastic and malignant lesion of the stomach, 1989-93.

• Establishment of diagnostic criteria for early detection of gastric cancer, 1985-89.

• Epidemiologic investigations on geographic characteristics of pathology of precancerous

change of the human stomach, 1982.

TEACHING EXPERIENCE

• Graduate students and fellows: pediatric pathology and laboratory technology, Laboratory of

Pediatric/Oncology, Robert H Lurie Comprehensive Cancer Center, Feinberg School of Medicine,

Northwestern University, Chicago, Illinois, 2001-05.

• Under and postgraduate students: anatomic pathology, Dept of Anatomic and Surgical

Pathology, Medical School, University of Beijing, Beijing, 1993-95.

• Postgraduates and visiting fellows: advance in tumor pathology and immunology, Cancer Inst

and Dept of Oncology, 1st Clinical College, China Medical University, Shenyang, 1988-90.

• Undergraduate students: anatomic pathology (laboratory skills and theory), 1982-84.

LEADERSHIP EXPERIENCE

• Assume leadership for Abbott Oncology ICSR medical review, 2009 - present.

• Supervising research technicians, intern students and medical fellows as Co-PI for NIH and NCI

Core Grant, 2003-2005.

• Supervising research assistants, 1998-01.

• Head of DNA Cytometry Laboratory, Dept of Pathology, School of Basic Medicine, Beijing,

Medical University, supervising graduate students, research fellows and research assistants.

• Advisor of MD candidates and principle investigator for 4 national funded research grants 1993-

96.

• Director Assistant, Cancer Institute and First Clinical College, China Medical University as Co-PI

for 7th National Five-Year Task Force Key Research Project, 1986-90.

• Member of Board Committee, Red Cross Hospital in charge of dept of Surgical Pathology,

Clinical Laboratory and Radiology, 1984-86.

• Head of Dept of Surgical Pathology, Red Cross Hospital, Shenyang, 1982-85.

HONORS/AWARDS

• Award for scientific achievement, Alexander von Humboldt Foundation of Germany (AVH)

including a Computer Assisted-Automatic CM1-DNA-Image-Cytometry-System (HUND Wetzlar,

Germany), 1993.

• International Competitive Fellowship, Alexander von Humboldt Foundation of Germany, 1990-

93.

• WHO International Exchange Research Fellowship, 1989.

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• Scientific Advance Award, Chinese National Ministry of Health (CNMH91-03), 1991.

• Award for Service Excellency as Surgical Pathologist, Red Cross Hospital, Shenyang, 1984, 85

and 86.

GRANT SURPPORTS

• Identification of angiogenesis inhibitors produced by Schwann cells and in Schwann cell-

conditioned media and determination of the inhibitors impeding angiogenesis and neuroblastoma

growth in vivo (NIH and NCI Core Grant, 5P30CA60553) as co-principle investigator at Robert H Lurie

Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, 2003-

2005.

• Application of 3D reconstruction and CLSM in clinical pathology, University of Vermont (SCH-

003) as principle investigator, 1995-96.

• Prognostic validity of DNA cytometry in clinical pathology, National Natural Sciences Foundation

of China (NSFF93-097) as principle investigator, 1993-96.

• Application of DNA aneuploidy as a marker for prospective malignancy in human cancer,

National Post-doctoral Foundation (NPDF93-05) as principle investigator, 1993-95.

• Specificity of DNA aneuploidy as a marker for prospective malignancy in human cancer,

National Educational Foundation (IRNEF93-044) as principle investigator, 1993-94.

• Establishment of histopathological criteria of precancerous lesions of human stomach, 7th

National Five-Year Task Force Key Research Project as co-principle investigator, 1986-1990.

SKILLS

Drug Safety:

• ICSR medical review of serious and non serious adverse events

• Causality assessment, alternative etiology and company analysis for expedited safety reporting.

• Benefit/risk assessment, Signal detection and aggregate safety analysis.

• ARISg, MedDRA coding, DQM and PT library construction for expedited reporting.

Good knowledge and many years research experiences in

• Surgical and anatomical Pathology

• Immunocyto(histo)chemistry

• Cytogenetics & Cell Biology

• DNA Image Cytometry

• Confocal Laser Scanning Microscope and 3D Reconstruction

• Computer

Academy Membership

• ASCO Membership since 2007

• DIA Membership since 2005

CITIZENSHIP: US Citizen

REFERENCES

Available upon request.

SELECTED PUBLICATIONS

Yang, Q., Tian, Y., Liu, S., Zeine, R., Chlenski, A., Salwen, H., Henkin, J., Cohn, S.:

1.

Thrombospondin-1 Peptide ABT-510 Combined with Valproic Acid is an Effective Anti-Angiogenesis

Strategy in Neuroblastoma, Cancer Research, 15.67(4):1716-24, 2007.

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Chlenski A., Liu S., Guerrero L.J., Yang Q., Tian Y., 1 Salwen H.R., Zage P, Cohn S.L. SPARC

2.

expression is associated with impaired tumor growth, inhibited angiogenesis, and changes in the

extracellular matrix. Int J Cancer. 15.118(2):310-6, 2006.

Jack Shuqing Liu, Andre Daniels, Judi Brenner, Heena Patel, George Dimitrov. Palmar-plantar

3.

Erythrodysesthesia Syndrome (PPES) - A Model of Proactive Signal Detection. International Regulatory

Affairs and Safety Meeting (IRASM) Thousand Oaks 2006.

George Dimitrov, Jack Shuqing Liu, Judy Page, Sean Zhao, Meghan Pruitt, Andre Daniels.

4.

The Assessment of Expectedness in Clinical Trials. International Regulatory Affairs and Safety Meeting (

IRASM) Thousand Oaks 2006.

Shuqing Liu and Susan Cohn. The Schwann Cell and Neuroblastoma Biology. Cancer Letter.

5.

18.228(1-2):125-31, 2005.

Shuqing Liu, Yufeng Tian, Alexandre Chlenski, Qiwei Yang, Peter Zage, Helen R. Salwen,

6.

Susan E. Crawford, and Susan L. Cohn. “Cross-talk” between Schwann Cells and Neuroblasts

Influences Biology of Neuroblastoma Xenograft. Am J Pathol, 166: 891-900, 2005.

Chlenski A, Liu S, Baker LJ, Yang Q, Tian Y, Salwen HR, Cohn SL. Neuroblastoma

7.

angiogenesis is inhibited with a folded synthetic molecule corresponding to the epidermal growth factor-

like module of the follistatin domain of SPARC. Cancer Res. 15.64(20):7420-5, 2004.

Yang Q, Liu S, Tian Y, Hasan C, Kersey D, Salwen HR, Chlenski A, Perlman EJ, Cohn

8.

SL.Methylation-associated silencing of the heat shock protein 47 gene in human neuroblastoma.

Cancer Res. 1.64(13):4531-8, 2004.

Q Yang, S Liu, Y Tian, H.R. Salwen, A Chlenski, J Weinstein, and S.L. Cohn. Methylation-

9.

associated Silencing of the Thrombospondin-1 Gene in Human Neuroblastoma. Cancer Res. 63: 6299-

6310, 2003.

A Chlenski, S Liu, S Chon. Regulation of Angiogenesis in Neroublastoma. Cancer Letter, 197,

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47-52, 2003.

Alexandre Chlenski, Shuqing Liu, Susan E. Crawford, Olga V. Volpert, Geoge H. DeVries, Amy

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Evangelista, Qiwei Yang, Helen R. Salwen, James Bray, and Susan L. Cohn. SPARC is a Key

Schwannian-derived inhibitor controlling neuroblastoma tumor growth and angiogenesis. Cancer

Research, 62: 7357-63, 2002.

Mohammed Kashani-Sabet, Yong Liu, Pierre-Yves Desprez, Shuqnig Liu, Guanghuan Tu,

12.

Mehdi Norsrati, Chakkrapong Handumrongkul, Denny Liggitt, Ann D. Thor, Robert J Debs: Identification

of gene function and functional pathways by systemic plasmid-based ribozyme targeting in adult mice.

Proc Natl Acad Sci. 19. 99(6):3878-83, 2002.

S Liu, DH Moore, EM Edgerton, AD Thor: Measures of Cell Turnover (Proliferation and

13.

Apoptosis) and Their Association with Survival in Breast Cancer, Clin. Cancer Res. 7(6):1716-23, 2001.

Thor AD, Edgerton SM, Liu S, Moore DH II, Kwiatkowski DJ. ErbB-2, EGFR and Gelsolin in

14.

Breast Cancer: Exploration of the master switch theory. Clin. Clin Cancer Res. 7(8):2415-24, 2001.

AD Thor, S Liu, and EM Edgerton, D Stern, M DiGiovanna: Activated erbB-2 Immunodetection

15.

using PN2A: Biologic and Prognosis Associations. JCO, 18: 3230-39, 2000.

Tu G, Kirchmaier AL, Liggitt D, Liu Y, Yu WH, Liu S, Heath TD, Thor A and Debs RJ. Non-

16.

replicating EBV-based plasmids extend gene expression and Improve gene therapy in vivo. JBC,

27(39). 30408-16, 2000.

AD Thor, S Liu, DH Moore, S Qiu, SM Edgerton: p21WAF1/CIP1 Expression in Breast Cancers:

17.

Association with p53 and Outcome. Breast Cancer Res. and Treat 61: 33-43, 2000.

S Liu, DH Moore, EM Edgerton, AD Thor: Measures of Cell Turnover (Proliferation and

18.

Apoptosis) and Their Association with Survival in Breast Cancer, Clin. Cancer Res. 7(6):1716-23, 2001.

AD Thor, S Liu, EM Edgerton, D Moore, and D Kwiatkowski: ErbB-2 and EGFR Interation with

19.

Gelsolin: A Motility Promoting Gene in Breast Cancers. Breast Cancer Res and Treat, 57(1). 136, 1999.

AD Thor, S Liu, EM Edgerton, D Stern, M DiGiovanna: ErbB-2, Activated erbB-2 and EGFR

20.

Immunoexpression in Breast Cancers. Breast Cancer Res and Treat, 57(1). 26, 1999.

AD Thor, S Liu, DH Moore and SM Edgerton: Comparison of Mitotic Index, In Vitro

21.

Bromodeoxyuridine labeling, and MIB-1 Assays to Quantitate Proliferation in Breast Cancer. J Clin

Oncol., 17. 470-477, 1999.

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S Liu, AD Thor, D Moore and EM Edgerton: Retrospective Analysis of Prognostic Factors in

22.

Invasive Ductal Carcinomas: Apoptosis, Proliferation and Oncogene Expression. Breast Cancer Res.

and Treat, 50(3). 228, 1998.

S Liu, DL Weaver, DJ Taatjes. Three Dimensional Reconstruction by Confocal Laser Scanning

23.

Microscopy in Routine Pathologic Specimens of Benign and Malignant Lesions of the Human Breast.

Histochm. Cell Biol., 107. 267-278, 1997.

S Liu, SM Edgerton SM, DH Moore, S Qiu, AD Thor: Aberrant Expression of p21WAF1/CIP1

24.

and p53 in Human Primary Breast Cancers: Association with Clinical, Histopathologic, Molecular and

Outcome Data in Breast Carcinoma. Breast Cancer Res. and Treat, 46(1). 29, 1997.

S Liu, DL Weaver, DJ Taatjes. 3D Reconstruction by CLSM in Routine Pathologic Specimens of

25.

Benign and Malignant Lesions of the Human Breast. Cell Vision, 3(3): 254, 1996.

Li X, He AG, Liu S.: Sensitivity of DNA Aneuploidy as a Marker in Diagnosing Pulmonary

26.

Carcinoma on Sputum Smears. Chin J Oncol. 1995.

Wang X, Liu S., Liu N.X., Gao Z.F., Gao R.L., Liao S.L., Wu B.Q. DNA Quantitation, Normal

27.

Dipoid Reference Cells and Their Correction Factors. Chin. J Pathol., 12:(24) 6, 390-392, 1995.

Liu S and Boecking A: Histopathologic Features and Cytometric Evidence for Potential

28.

Precancerous Lesion of Diffuse Type Gastric Cancer: Tuboid Dysplasia. 1-95 Verlag Shaker, Germany

(ISBN 3-86111-352-X), 1993

Boecking A, Biesterfeld, S., Liu S.: DNA Distribution in Gastric Cancer and dysplasia. In Zhang

29.

Y.C. et al. (eds): Precancerous Conditions and Precancerous Lesions of the Stomach. Springer-Verlag,

Heidelberg, F.R. Germany. p. 102-120, 1992.

Liu S., Zhang Y.C., Kropff M., Böcking A.: DNA-Aneuploidy as a Marker for Prospective

30.

Malignancy in Gastric Dysplasia. Pathol Res Pract. 187(6): 716, 1991.

Bisterfeld S., Baerbel S.O., Liu S., Böcking A.: DNA-Zytometrischer Nachweis von Prospektiver

31.

Malignität in Dysplasien der Magenscleimhaut. Verh. Dtsch. Ges. Path. 74, 499, 1990.

Liu S., Zhang Y.C.: Characteristics of Mucins and CEA in Globoid Dysplastic Cells of Human

32.

Gastric Mucosa and Its Relationship with Signet Ring Cell Carcinoma. Chin. J Oncol. 11(3). 176-179,

1989.

Liu S., Zhang Y.C.: A Newly Recognized Precancerous Lesion of the Stomach: Histopathologic

33.

Features of Globoid Dysplasia of Human Gastric Epithelium. Chin. J Cancer Res. 1(5). 19-24, 1989.

Zhang Y.C., Zhang P.F., Wang M.X., Liu S.: Histopathologic Types of Gastric Dysplasia. Ch.

34.

Cancer Res.1(1). 47-52, 1988.

Liu S. and Zhang Y.C.: Cytochemical and Immunohistochemical Study on Globoid Dysplasia

35.

(III). J Ch Med Univ.17(2). 98-102, 1988.

Liu S., Zhang Y.C.: The Histopathologic Classification and Its Association with Signet Ring Cell

36.

Carcinoma, Globoid Dysplasia (II). J Ch Med Univ.17 (1). 1-6, 1988.

Liu S., Zhang Y.C.: A Newly Recognized Precancerous Lesion of the Stomach: Globoid

37.

Dysplasia (I). J Ch Med Univ. 16(5). 322-326, 1987.

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