`George M. Grass IV
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`Office
`G2 Research
`PO Box 1242
`Tahoe City, CA 96145
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`EDUCATION
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`Phone: 530-581-2717
`Fax: 815-346-5885
`E-Mail: G2Research@gmail.com
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`• August, 1985: Ph.D. Pharmaceutics. University of Wisconsin, Madison, Wisconsin. Thesis title:
`Mechanisms of Corneal Drug Penetration.
`1980-1983: MS Pharmaceutics. University of Wisconsin, Madison, Wisconsin. Thesis title:
`Relationship of Chemical Structure to Corneal Penetration for Small Organic Compounds.
`1977-1980: Pharm.D. University of Nebraska Medical Center, Omaha, Nebraska. Licensed to
`practice pharmacy in Nebraska.
`1975-1977: Pre-Pharmacy, University of Nebraska, Lincoln, Nebraska.
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`EXPERIENCE
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`• August 2001 – Present: President G2 Research, industry consultant to drug discovery and
`biotechnology organizations, and investors. Engaged in corporate strategy, product development,
`formulation development, pharmacokinetic analysis, CRO management, investor diligence, and
`expert witness. Development and licensing of iDEA pharmacokinetic simulation software and
`databases (www.admedata.com, and www.admemodel.com).
`July 2010 - Present: Board member and Acting CEO of Bamboo Bottle Company, a unique consumer
`products company (www.bamboobottleco.com)
`• Aug 2007 - Aug 2010: Sr. Vice President of Research and Development, Sorbent Therapeutics, a
`company developing novel therapeutics for sodium and fluid removal. Responsibilities including:
`corporate strategy, planning and execution; identification, evaluation, integration and management of
`outside technologies and services. Develop novel technology and product formulation strategy.
`Assist in representing the company to potential partners and investors.
`• May 2005 – Mar 2007: Vice President of Product Development and Chief Technology Officer, PDxRx
`Inc. a subspecialty focused pediatrics company. Responsibilities including: corporate management
`and strategy; identification and negotiation of new product/technology opportunities. Assist in
`representing the company to potential partners and investors.
`1999-August 2001: Chief Technology Officer, Corporate Officer, Trega Biosciences (acquired by Lion
`bioscience 4/2001) – corporate management and strategy; identification, evaluation and negotiation
`of outside technologies; technical development of iDEA pharmacokinetic simulation software;
`presentation of corporate technology and strategy to and negotiation with customers, collaborators,
`scientific community and current and prospective investors.
`1997-2008: Founder and Vice President RaptorGraphics, Inc., Seattle WA (acquired by MDE
`Engineering Inc.). Corporate management and technical / strategic development of computer
`graphics and simulation business targeted to legal applications.
`1996-1999: Founder, President, CEO and Chief Business Officer, NaviCyte, Inc. (acquired by Trega
`Biosciences 11/1999) – Responsible for all corporate/financial/strategic management and
`establishment of all contracts/licenses. Design of new products, establishment of contract service
`organization, development of simulation models to predict pharmacokinetics and
`pharmacodynamics. Establishment of Pharma consortium for development of ADME simulation
`software.
`1987 -1996: Founder, President and CEO of Precision Instrument Design, Inc., Tahoe City, CA.
`Design, manufacture, and marketing of laboratory equipment for conducting basic research in drug
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`MYLAN - EXHIBIT 1003
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`delivery. Responsible for all corporate/financial/strategic management. Development of simulation
`models to predict pharmacokinetics and pharmacodynamics.
`1991 - 1996: Pharmaceutical industry consultant on drug delivery subjects including oral delivery,
`controlled release, peptide and protein delivery, ocular drug delivery and simulation modeling of
`various drug delivery related issues.
`1985-1991: Staff Researcher I / II, Pharmaceutical Development, Dosage Design and Development,
`Institute of Pharmaceutical Sciences, Syntex Research, Palo Alto, California. Development of early
`stage (pre IND, IND and pre NDA) compounds for oral delivery. Basic research in mechanisms of
`oral absorption including methods to orally deliver peptides. Computer modeling and
`pharmacokinetic simulations. Supervision of two BS/MS positions, one Post Doctoral Fellow and
`various interns.
`1983-1985: Computer sales and installation, CBM Computer Center, Madison, Wisconsin. Sales and
`installation of microcomputers. Network installations and troubleshooting.
`1980-1985: Teaching (Pharmaceutics and Pharmaceutical Dispensing laboratory classes) / Research
`Assistant, University of Wisconsin, Madison, Wisconsin.
`1980: Research Technician, Creighton University, Omaha, Nebraska. Fabrication of gels and matrices
`from various polymers for ocular inserts. Conducted ocular pharmacokinetic determinations using
`measurements of miosis in rabbits.
`1977-1979: Research Technician, Product Development, Streck Laboratories, Omaha, Nebraska.
`Developed methods for fixation, cryoprotection of platelets and red blood cells. Product
`development of latex calibration standards for various cell counters.
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`AWARDS, HONORS, AFFILIATIONS
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`Co-recepient 1989 Ebert Prize
`Sigma Xi Scientific Research Society
`Rho Chi Pharmacy Honor Society
`Member, American Association Pharmaceutical Sciences
`Member, Controlled Release Society
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`PATENTS
`G.M. Grass and S.A. Sweetana, An apparatus for the determination of transport across tissues,
`membranes or cell cultures, US Patent #5,183,760, Feb 2, 1993.
`
`G.M. Grass, Membrane Holder, US Patent # 5,591,636, Jan 7, 1997.
`
`G.M. Grass, Device and method for circulating fluid over a membrane., US Patent # 5,599,688 Feb 4, 1997.
`
`G.M. Grass and S.A. Sweetana, Polypeptide composition for oral administration US Patent # 6,156,731
`
`December 5, 2000.
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`G.M. Grass, Packing device for transporting confluent cell monolayers, US Patent # 6,146,883 November
`14, 2000.
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`G.M. Grass, G.D. Leesman, D.A. Norris, P.J. Sinko, J.E. Wehrli, Method for producing and screening
`compound libraries., US Patent # 6,996,473 Feb 7, 2006.
`
`G.M. Grass, G.D. Leesman, D.A. Norris, P.J. Sinko, J.E. Wehrli, Pharmacokinetic-based drug design tool
`and method., US Patent #6,542,858 April 1, 2003.
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`0002
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`G.M. Grass, G.D. Leesman, D.A. Norris, P.J. Sinko, J.E. Wehrli, Pharmacokinetic-based drug design tool
`and method., US Patent #6,647,358 Nov 11, 2003.
`
`M. Schwartz and G.M. Grass, Unitary Pharmaceutical Composition , Method, and Kit for the Treatment
`or Prevention of Metabolic or Endocrine Disorders, PCT/US2007/07/079889.
`
`A. Strickland and G. Grass, Polymeric Compositions with Enhanced Saline Holding Capacity and Their
`Method of Preparation and Use., PCT/US2008/074847.
`
`A. Strickland and G. Grass, Polymeric Compositions and Their Method of Use in Combination with
`Active Agents., PCT/US2008/074848.
`
`A. Strickland and G. Grass, Absorbent Polymeric Compositions with Varying Counterion Content and
`Their Methods of Preparation and Use, PCT/US2008/074861.
`
`PUBLICATIONS
`G.M. Grass, J. Cobby, and M.C. Makoid, Ocular delivery of pilocarpine from erodible matrices. J. Pharm.
`Sci. 73,618-621 (1984).
`
`G.M. Grass, J.R. Robinson, Relationship of chemical structure to corneal penetration and influence of low-
`viscosity solutions on ocular bioavailability. J. Pharm. Sci. 73,1021-1027 (1984).
`
`G.M. Grass, R.W. Wood, and J.R. Robinson, Effects of calcium chelating agents on ocular tissue
`permeability. Invest. Ophthalmol. Vis. Sci. 26:110-113(1985).
`
`G.M. Grass and J.R. Robinson, Mechanisms of Corneal Drug Penetration I. In vivo and in vitro kinetics, J.
`Pharm. Sci. 77:3-14 (1988).
`
`G.M. Grass and J.R. Robinson, Mechanisms of Corneal Drug Penetration II. Ultrastructural Analysis of
`Potential Pathways for Drug Movement, J. Pharm. Sci. 77:15-23 (1988).
`
`G.M. Grass and J.R. Robinson, Mechanisms of Corneal Drug Penetration III. Modeling of Molecular
`Transport, J. Pharm. Sci. 77:24-26 (1988).
`
`G.M. Grass and S.A. Sweetana, In vitro measurement of gastrointestinal tissue permeability using a new
`diffusion cell., Pharm Res., 5:372 (1988).
`
`G.M. Grass and W.T. Morehead, Evidence for site specific absorption of a novel ACE-inhibitor., Pharm
`Res 6:759 (1989).
`
`G. M. Grass and S.A. Sweetana, A correlation of permeabilities for passively transported compounds in
`monkey and rabbit jejunum., Pharm. Res., 6: 857 (1989).
`
`G.M. Grass and J.R. Robinson, Sustained and controlled release drug delivery systems. In: Modern
`Pharmaceutics, G.S. Banker and C.T. Rhodes, ed., Marcel Dekker, inc., New York, New York. (1990).
`
`G.M. Grass, S.A. Sweetana, and C. Bozarth, The effects of enprostil and RS-86505-007 on in vitro intestinal
`permeability of rabbit and monkey., J. Pharm. Pharmacol, 42:40-44 (1990).
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`W. Rubas, N. Jezyk, R. Kos and G. M. Grass, In vitro transport characteristics of Peyer's patches for
`passively and actively transported compounds, Proceed. Intern. Symp. Control. Rel. Bioact. Mater., (1990).
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`0003
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`G.M. Grass and V.L. Lee, A STELLA® model to predict aqueous humor and plasma drug concentrations
`form topical dosing to the eye., Proceed. Intern. Symp. Control. Rel. Bioact. Mater., (1990).
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`V. H-L Lee, S. Doddakashi, G.M. Grass, W. Rubas, Oral route of peptide and protein drug delivery., in V.
`H-L Lee (ed.) Peptide and Protein Drug Delivery: Fundamentals and Technology, Marcel Dekker, New
`York, 1991.
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`M.W. Ramsay, G.M. Grass, and J.J. Vallner, Pharmacokinetic simulations using Stella: prediction of in vivo
`performance of oral dosage forms., Eur. J. Pharm. and Biopharm., 37:192-7 (1991).
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`I.H. Hidalgo, K.M. Hilgren, G.M. Grass, and R.T. Borchardt, Characterization of the unstirred water layer
`in CACO-2 cell monolayers using a novel diffusion apparatus, Pharm. Res., 8:, 222-227 (1991).
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`W. Rubas and G.M. Grass, Review: Gastrointestinal lymphatic absorption, Adv. Drug Del. Rev., 7:15-69
`(1991).
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`S. Ohdo, G.M. Grass, and V. H-L. Lee, Improving the ocular:systemic ratio of topical timolol by varying
`the dosing time., Invest. Ophthalmol. and Vis. Sci. , 32:2790-98 (1991).
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`V.H.L. Lee, A.M. Luo, S. Li, S.K. Podder, J. S-C. Chang, S. Ohdo, and G.M. Grass, Pharmacokinetic basis
`for nonadditivity of intraocular pressure lowering in timolol combinations. Invest. Ophthalmol. and Vis.
`Sci. , 32:2948-2957 (1991).
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`I.H. Hidalgo, K.M. Hilgren, G.M. Grass, and R.T. Borchardt, A new side-by-side diffusion cell for
`studying transport across epithelial cell monolayers In Vitro., In Vitro Cell Dev. Biol., 28A: 578-580 (1992).
`
`N. Jezyk, W. Rubas and G.M. Grass, Permeability Characteristics of Various Intestinal Regions of Rabbit,
`Dog, and Monkey, Pharm. Res. 9:1580-1586 (1992).
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`W. Rubas, N. Jezyk, and G.M. Grass, Linear relationship between the permeability of a human colon
`adenocarcinoma cell line (Caco-2) and rabbit colon., Proceed. Intern. Symp. Control. Rel. Bioact. Mater.,
`12:306 (1992).
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`W. Rubas, N. Jezyk, and G.M. Grass, Comparison of the Permeability characteristics of a human colonic
`epithelial (Caco-2) cell line to colon of Rabbit, Monkey, and Dog Intestine, and Human Drug Absorption,
`Pharm. Res. 10:113 (1993).
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`G.M. Grass and V.H.L. Lee, A model to Predict Aqueous Humor and Plasma Pharmacokinetics of
`Ocularly Applied Drugs, Invest. Ophthalmol. and Vis. Sci., 34:2251-2259 (1993).
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`K. Ng, H. Lane, G. Grass, and R.T. Borchardt, Characterization of the unstirred water layer in cultured
`brain microvessel endothelial cells., In Vitro Cell. Dev. Biol., 29A:627-629 (1993).
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`G. M.. Grass, C. A.. Bozarth, and J. J. Vallner, Evaluation of the Performance of Controlled Release Dosage
`Forms of Ticlopidine Using In Vitro Intestinal Permeability and Computer Simulations, J. Drug Targeting,
`2:23-33 (1994).
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`W. Rubas, N. Jezyk, and G.M. Grass, Mechanism of Dextran Transport Across Rabbit Intestinal Tissue and
`a Human Colon Cell-Line (Caco-2), J. Drug Targetting, 3:15-21 (1995).
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`G. M. Grass, Simulation models to predict oral drug absorption from in vitro data, Advanced Drug
`Delivery Reviews, 23:199-219 (1997).
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`D.A. Norris, G. D. Leesman, P.J. Sinko, G. M. Grass, Development of predictive pharmacokinetic
`simulation models for drug discovery, J. of Controlled Release, 65: 55-62 (2000).
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`G.M. Grass and P.J. Sinko, Effect of diverse datasets on the predictive capability of ADME models in drug
`discovery., Drug Discovery Today, June Vol 6, Suppl 1: 54-61 (2001).
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`G.M. Grass and P.J. Sinko, Physiologically-based pharmacokinetic simulation modeling
`Adv Drug Deliv Rev Mar 31;54(3):433-51 (2002).
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`P.V. Paranjpe, G. M. Grass and P. J. Sinko, In Silico Tools for Drug Absorption Prediction: Experience to
`Date, Am J Drug Deliv 1(2) 133-148 (2003).
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`ABSTRACTS AND PRESENTED PAPERS (sample)
`G.M. Grass, J.C. Cobby and M.C. Makoid, Ocular delivery of pilocarpine from bioerodible matrices., APS
`American Pharmaceutical Association., Kansas City, Missouri. November 1980.
`
`G.M. Grass and J.R. Robinson, Relationship of chemical structure to corneal penetration for small organic
`compounds., Academy of Pharmaceutics, American Pharmaceutical Association., San Diego, California.
`November 1983.
`
`G.M. Grass and J.R. Robinson, Effects of chelating agents on corneal permeability., First Annual Technical
`Meeting, Wisconsin Pharmaceutics Research Consortium, Madison, Wisconsin, March 1983.
`
`G.M. Grass and J.R. Robinson, Mechanisms of epithelial permeability., Second Annual Technical Meeting,
`Wisconsin Pharmaceutics Research Consortium, Madison, Wisconsin, March 1984.
`
`G.M. Grass and S.A. Sweetana, Correlation of passive diffusional transport in monkey and rabbit
`jejunum., International Congress of Pharmaceutical Sciences of F.I.P., Amsterdam, The Netherlands, Sept.
`1987.
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`K. Cahill, S. Sweetana, and G.M. Grass, Evaluation of the comparative oral absorption of a prodrug and
`its parent compound using an in vitro system., AAPS Regional, Reno Nevada, January 1988.
`
`L. Chee, S.A. Sweetana, and G.M. Grass, Correlation of active transport of glucose and intracellular levels
`of ATP in monkey and rabbit jejunum., AAPS Regional, Reno Nevada, January 1988.
`
`G.M. Grass, S.A. Sweetana, and C. Bozarth, Effect of enprostil and RS-86505 on in vitro intestinal
`permeability of actively and passively transported compounds., AAPS Regional, Reno Nevada, January
`1988.
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`M.W. Ramsay, G.M. Grass, and J.J. Vallner, A novel computer model for predicting performance of
`controlled release dosage forms., AAPS Regional, Reno Nevada, January 1988.
`
`G.M. Grass, S.A. Sweetana, K.M. Cahill, and J.J. Vallner, A method for determination of the relative
`intestinal permeabilities of a prodrug and its active moiety., Third International Conference on Drug
`Absorption, Edinburgh, UK (1988).
`
`G.M. Grass and C.A. Bozarth, Evidence for gastrointestinal metabolism and metabolite absorption of
`ticlopidine. AAPS Western Regional Meeting Reno, Nevada (1989).
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`G. M. Grass and W.T. Morehead, The use of STELLA to describe site-specific absorption for a novel ace-
`inhibitor, AAPS Western Regional Meeting Reno, Nevada (1989).
`
`I.J. Hidalgo, K. Hillgren, G.M. Grass and R.T. Borchardt, Permeability of CACO-2 cell monolayers in a
`novel diffusion cell., AAPS Western Regional Meeting Reno, Nevada (1989).
`
`I.J. Hidalgo, K. Hillgren, G.M. Grass and R.T. Borchardt, Characterization of the aqueous boundary layer
`in CACO-2 cells using a novel diffusion cell., Pharm Res. 6:S114 (1989).
`
`R. Kos and G. M. Grass, A novel method for manufacture of enteric coated capsules., AAPS Western
`Regional Meeting Reno, Nevada (1990).
`
`N. Jezyk, R. Kos, W. Rubas, and G.M. Grass, In vitro intestinal segment permeability differences in rabbit,
`dog, and monkey., AAPS Las Vegas, NV (1990).
`
`W. Rubas, N. Jezyk, R. Kos and G.M. Grass, Comparison of in vitro absorptive pinocytosis in rabbit
`Peyer’s patch and non patch tissue. AAPS Western Regional Meeting Reno, Nevada (1991).
`
`N. Jezyk, W. Rubas, and G.M. Grass, Comparison of the in vitro intestinal permeability of rabbit monkey
`and dog. AAPS Western Regional Meeting Reno, Nevada (1991).
`
`G.M.Grass, W. Rubas, and N. Jezyk, Evaluation of CACO-2 monolayers as a predictor of drug
`permeability in colonic tissues., FASEB Journal, 6:4, A1002 (1992).
`
`G.M.Grass, A simulation model to predict oral drug absorption from in vitro permeability studies., CRS
`Oral Drug Delivery, Kuopio, Finland (1993).
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`W. Rubas, N. Jezyk, and G.M. Grass, Mechanism of dextran transport across rabbit intestinal tissue and a
`human colon cell line (CACO-2), World Congress on Alternatives and Animal Use in the Life Sciences.,
`Baltimore, MD. (1993).
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`G.M.Grass, A mathematical model to predict oral drug absorption from in vitro permeability studies.,
`World Congress on Alternatives and Animal Use in the Life Sciences., Baltimore, MD. (1993).
`
`G.M. Grass, Simulation models to predict oral drug absorption from in vitro permability studies.,
`American Association of Pharmacuetical Scientists, Miami, FL (1995).
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`H. Yu, G. M. Grass, P. J. Sinko, Characterization of Caco-2 cells grown on polyester and polycarbonate
`microporous membranes, AAPS 95 Annual Meeting, Miami, FL (1995).
`
`G. M. Grass, Simulation models to predict oral drug absorption, IBC 3rd Annual International Conference
`on Pharmacokinetic / Pharmacodynamic Analysis, Washington, D.C. (1997).
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`G. M. Grass, In vitro permeability studies and computer simulation modeling for the prediction of drug
`absorption in humans, The Third Lake Tahoe Symposium on Molecular Diversity, California (1999).
`
`G. M. Grass, Computational pharmacokinetics for drug discovery – interfacing high throughput
`pharmacokinetics (HTPkS) and pk-informatics, CBI Optimizing Lead Selection and Early Attrition,
`Philadelphia, PA (1999).
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`G. M. Grass, Predictive simulated modeling in drug discovery, Bio 2000, Boston, MA (2000).
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`G. M. Grass, Predictive modeling for early ADME evaluation in drug discovery, SRI 2nd International
`New Technologies to Increase Drug Candidate Survivability, Philadelphia, PA (2000).
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`G. M. Grass, Predictive modeling for early ADME evaluation in drug discovery, SBS 6th Annual
`Screening in the New Millennium, Vancouver, B.C. Canada (2000).
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`G. M. Grass, iDiscovery: Information based lead optimization, ADME Study in Drug Discovery
`Conference, Kyoto, Japan (2000).
`
`G. M. Grass, Predictive modeling for early ADME evaluation in drug discovery, IBC 3rd Annual, Early
`ADME and Toxicology in Drug Discovery, La Jolla, CA (2000).
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`R. J. Christopher, Y.H. Lee, A. Schmitt-Hoffman, N. Rogers, J. Doerr-Stevens, W. P. Gordon, K. J. Lee, N.
`Johnson, J. Castelo, J. Zhang-O’Brien, B. Phan, T. Hollenbeck, P.J. Sinko, G. M. Grass, A case study:
`Selection of a diversified set of compounds for in vitro profiling for validation testing using the IDEA
`predictive model, Drug Discovery Technologies Conference, Boston, MA (2000).
`
`G. Leesman, D. Norris, G. Timony, Y. Chen, W. Pirson, F.P. Theil, A. H. Schmitt-Hoffman, Y. H. Lee, J.
`Doerr-Stevens, P. Gordon, R. Retajczyk, S. Tran, N. Johnson, J. Castelo, R. Christopher, G. M. Grass, P. J.
`Sinko, Assesment of the physiologically-based IDEA predictive model using an external (blinded) data
`set, AAPS Annual Meeting, Indianapolis, (2000).
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`C. Sage, N. Johnson, Y. Lee, R. Christopher, P. Gordon, T. Hollenbeck, B. Phan, P. J. Sinko, A. Hillyard, G.
`M. Grass, In silico prediction of Caco-2 permeability from molecular structure, AAPS Annual Meeting,
`Indianapolis, (2000).
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`G. Timony, D. A. Norris, G. D. Leesman, R. Retajczyk, S. Tran, Y. Chen, Y. Lee, N. Johnson, J. Castelo, K.J.
`Lee, R. J. Christopher, P. J. Sinko, G. M. Grass, Development and validation of the physiologically based
`IDEA predictive model, AAPS Annual Meeting, Indianapolis, (2000).
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`Y. H. Lee, N. Johnson, K. J. Lee, J. Castelo, K. Click, P. Gordon, T. Hollenbeck, B. Phan, R. J. Christopher, G.
`M. Grass, P. J. Sinko, Utility of a 24-well format of Caco-2 monolayer for absorption screening and
`prediction, AAPS Annual Meeting, Indianapolis, (2000).
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`K. J. Lee, Y. H. Lee, N. Johnson, J. Castelo, K. Click, P. Gordon, T. Hollenbeck, B. Phan, R. J. Christopher, G.
`M. Grass, P. J. Sinko, Comparison of the permeability characteristics of BCS compounds in various
`intestinal regions of rabbit and Caco-2 models, AAPS Annual Meeting, Indianapolis, (2000).
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`0007