# References

### References & Information

#### 1

A. C. Andersen. *The beagle as an experimental dog*. Iowa State University Press. University of Michigan. 616 pages. 1970.

#### 2

[N. Balakrishnan (Editor). *Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods*. John Wiley and Sons. 2014.](https://www.wiley.com/en-us/Methods+and+Applications+of+Statistics+in+Clinical+Trials,+Volume+2%3A+Planning,+Analysis,+and+Inferential+Methods-p-9781118304761)

#### 3

[L. Baxter, H. Zhu, D. Mackensen, and R. Jain. *Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice*. Cancer Research. 54. 1517-28. 1994.](https://pubmed.ncbi.nlm.nih.gov/8137258)

#### 4

[L.Z. Benet. *Basic Principles and Its Use as a Tool in Drug Metabolism*. in: Drug Metabolism and Drug Toxicity. J.R. Mitchell. M.G. Horning. Raven Press. New York, USA. pp. 199. 1984.](https://doi.org/10.1002/em.2860070617)

#### 5

[L.M. Berezhkovskiy. *Volume of distribution at steady state for a linear pharmacokinetic system with peripheral elimination*. Journal of Pharmaceutical Sciences. 93(6). 1628-40. 2004.](https://pubmed.ncbi.nlm.nih.gov/15124219)

#### 6

[A. C. Hindmarsh, P. N. Brown, K. E. Grant, S. L. Lee, R. Serban, D. E. Shumaker, and C. S. Woodward. *SUNDIALS: Suite of Nonlinear and Differential/Algebraic Equation Solvers*. ACM Transactions on Mathematical Software, 31(3), pp. 363-396, 2005.](https://computing.llnl.gov/sites/default/files/toms_sundials.pdf)

#### 7

[P. Costa and J. M. Sousa Lobo. *Modeling and comparison of dissolution profiles*. Eur J Pharm Sci. 13(2). 123-33. 2001.](https://pubmed.ncbi.nlm.nih.gov/11297896)

#### 8

C. Crone and D.G. Levitt. *Capillary permeability to small solutes*. in Handbook of Physiology: The Cardiovascular System: Microcirculation. E.M. Renkin. C.C. Michel. American Physiological Society. Bethesda, MD, USA. pp. 411–466. 1984.

#### 9

[C. Dordas and P. H. Brown. *Permeability of Boric Acids across Lipid Bilayers and Factors Affecting it*. Journal of Membrane Biology. 175. 95-105. 2000.](https://pubmed.ncbi.nlm.nih.gov/10811971)

#### 10

[J.B. Dressman, K. Thelen, and E. Jantratid. *Towards Quantitative Prediction of Oral Drug Absorption*. Clinical Pharmacokinetics. 47(10). 655-67. 2008.](https://pubmed.ncbi.nlm.nih.gov/18783296)

#### 11

[A. N. Edginton, S. Willmann, B. Voith, and W. Schmitt. *A mechanistic approach to the scaling of clearance in children*. Clinical Pharmacokinetics. 45. 683-704. 2006.](https://pubmed.ncbi.nlm.nih.gov/16802850)

#### 12

[A. N. Edginton, W. Schmitt, and S. Willmann. *Application of physiology-based pharmacokinetic and pharmacodynamic modeling* towards individualized propofol target controlled infusion. Advances in Therapy. 23. 143-158. 2006.](https://pubmed.ncbi.nlm.nih.gov/16644615/)

#### 13

[A. N. Edginton, W. Schmitt, and S. Willmann. *Development and evaluation of a generic physiologically based pharmacokinetic model for children*. Clinical Pharmacokinetics. 45. 1013-1034. 2006.](https://pubmed.ncbi.nlm.nih.gov/16984214)

#### 14

[A. N. Edginton, F.P. Theil, W. Schmitt, and S. Willmann. *Whole body physiologically-based pharmacokinetic models: their use in clinical drug development*. Expert Opinion on Drug Metabolism & Toxicology. 4(9). 1143-52. 2008.](https://pubmed.ncbi.nlm.nih.gov/18721109)

#### 15

[A.N. Edginton, G. Ahr, S. Willmann, and H. Stass. *Defining the Role of Macrophages in Local Moxifloxacin Tissue Concentrations using Biopsy Data and Whole-Body Physiologically Based Pharmacokinetic Modelling*. Clinical Pharmacokinetics. 48(3). 181-7. 2009.](https://pubmed.ncbi.nlm.nih.gov/19385711)

#### 16

[A. N. Edginton and G. Joshi. *Have physiologically-based pharmacokinetic models delivered?*. Expert Opin Drug Metab Toxicol. 929-34. 7(8). 2011.](https://pubmed.ncbi.nlm.nih.gov/21762039)

#### 17

[A. N. Edginton and S. Willmann. *Physiology-based simulations of a pathological condition : prediction of pharmacokinetics in patients with liver cirrhosis*. Clinical Pharmacokinetics. 47(11). 743-52. 2008.](https://pubmed.ncbi.nlm.nih.gov/18840029)

#### 18

[T. Eissing, L. Kuepfer, C. Becker, M. Block, K. Coboeken, T. Gaub, L. Goerlitz, J. Jaeger, R. Loosen, B. Ludewig, M. Meyer, C. Niederalt, M. Sevestre, H. U. Siegmund, J. Solodenko, K. Thelen, U. Telle, W. Weiss, T. Wendl, S. Willmann, and J. Lippert. *A computational systems biology software platform for multiscale modeling and simulation: integrating whole-body physiology, disease biology, and molecular reaction networks*. Front Physiol. 4. 2. 2011.](https://pubmed.ncbi.nlm.nih.gov/21483730)

#### 19

[T. Eissing, J. Lippert, and S. Willmann. *Pharmacogenomics of Codeine, Morphine, and Morphine-6-Glucuronide: Model-Based Analysis of the Influence of CYP2D6 Activity, UGT2B7 Activity, Renal Impairment, and CYP3A4 Inhibition*. Mol Diagn Ther. 43-53. 16(1). 2012.](https://pubmed.ncbi.nlm.nih.gov/22352453)

#### 20

[C.T. Ekstrom (Editor). *Introduction to Statistical Data Analysis for the Life Sciences, Second Edition*. CRC Press. 2014.](https://doi.org/10.1201/b17625)

#### 21

[B. I. Escher and R. P. Schwarzenbach. *Partitioning of Substituted Phenols in Liposome-Water, Biomembrane-Water, and Octanol-Water Systems*. Environmental Science and Technology. 30. 260-270. 1996.](https://doi.org/10.1021/es9503084)

#### 22

[P. Espie, D. Tytgat, M. L. Sargentini-Maier, I. Poggesi, and J. B. Watelet. *Physiologically based pharmacokinetics (PBPK)*. Drug Metab Rev. 41. 391-407. 2009.](https://pubmed.ncbi.nlm.nih.gov/19601719)

#### 23

[L. Fahrmeir, T. Kneib, and S. Lang. *Regression Modelle, Methoden und Anwendungen*. Springer Verlag. 2009.](https://www.springer.com/de/book/9783642018367)

#### 24

[F. Frezard and A. Garnier-Suillerot. *Permeability of Lipid Bilayer to Anthracycline Derivates. Role of the Bylayer Composition and of the Temperature*. Biochimica et Biophysica Acta. 1389. 13-22. 1998.](https://pubmed.ncbi.nlm.nih.gov/9443599)

#### 25

[E. Galia, E. Nicolaides, D. Härter, R. Läbenberg, C. Reppas, and J. B. Dressman. *Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs*. Pharmaceutical Research. 15. 698-705. 1998.](https://pubmed.ncbi.nlm.nih.gov/9619777)

#### 26

[A. Garg and J. Balthasar. *Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice*. Journal of Pharmacokinetics and Pharmacodynamics. 34. 687-709. 2007.](https://pubmed.ncbi.nlm.nih.gov/17636457)

#### 27

\[Henri P. Gavin. *The Levenberg-Marquardt method for nonlinear least squares curve-fitting problems*. 2016.]\(<https://people.duke.edu/%7Ehpgavin/> <https://people.duke.edu/\\~hpgavin/ce281/lm.pdf>)

#### 28

[X. Ge, S. Yamamoto, S. Tsutsumi, Y. Midorikawa, S. Ihara, S. M. Wang, and H. Aburatani. *Interpreting expression profiles of cancers by genome- wide survey of breadth of expression in normal tissues*. Genomics.. 86(2). 127-41. 2005.](https://pubmed.ncbi.nlm.nih.gov/15950434/)

#### 29

[R. Gebhardt. *Metabolic zonation of the liver: Regulation and implications for liver function*. Pharmacol. Ther.. 53(3). 275-354. 1992.](https://pubmed.ncbi.nlm.nih.gov/1409850)

#### 30

[J. A. Goldsmith, N. Randall, and S. D. Ross. *On methods of expressing dissolution rate data.*. J Pharm Pharmacol. 30(6). 347-9. 1978.](https://pubmed.ncbi.nlm.nih.gov/26763)

#### 31

[H. W. Haagard. *The Absorption, Distribution and Elimination of Ethyl Ether*. The Journal of Biological Chemistry. 59. 753-770. 1924.](https://www.sciencedirect.com/science/article/pii/S0021925818852589)

#### 32

[M. W. Härter, J. Keldenich, and W. Schmitt. in Handbook of Combinatorial Chemistry. Vol. 2. K. C. Nicholaou. R. Hanko. W. Hartwig. Wiley-VCH. Weinheim, Germany. 2002.](https://onlinelibrary.wiley.com/doi/10.1002/3527603034.ch26)

#### 33

[W. L. Hayton. *Maturation and Growth of Renal Function: Dosing Renally Cleared Drugs in Children*. AAPS PharmSci. 2(1). E3. 2002.](https://pubmed.ncbi.nlm.nih.gov/11741219)

#### 34

[P. Holliger and P. J. Hudson. *Engineered antibody fragments and the rise of single domains*. Nat Biotechnol.. 23(9). 1126-36. 2005.](https://pubmed.ncbi.nlm.nih.gov/16151406)

#### 35

[H. G. Holzhutter, D. Drasdo, T. Preusser, J. Lippert, and A. M. Henney. *The virtual liver: a multidisciplinary, multilevel challenge for systems biology*. Wiley Interdiscip Rev Syst Biol Med. 2012.](https://pubmed.ncbi.nlm.nih.gov/22246674)

#### 36

[R. Kawei, M. Lemaire, J. L. Steimer, A. Bruelisauer, W. Niederberger, and M. Rowland. *Physiology Based Pharmacokinetic Study on a Cyclosporin Derivate, SDZ IMM 125*. Journal of Pharmacokinetics and Biopharmaceutics. 22. 327-365. 1994.](https://pubmed.ncbi.nlm.nih.gov/7791036)

#### 37

[G. Kersting, S. Willmann, G. Wurthwein, J. Lippert, J. Boos, and G. Hempel. *Physiologically based pharmacokinetic modelling of high- and low-dose etoposide: from adults to children*. Cancer Chemother Pharmacol. 397-405. 69(2). 2012.](https://pubmed.ncbi.nlm.nih.gov/21789689)

#### 38

[B. Krippendorf, R. Neuhaus, and P. Lienau. *Mechanism-Based Inhibition: Deriving KI and kinact Directly from Time-Dependent IC50 Values*. J. of Biomolecular Screening. 14((8). 2009.](https://pubmed.ncbi.nlm.nih.gov/19675314)

#### 39

[L. Kuepfer, J. Lippert, and T. Eissing. *Multiscale mechanistic modeling in pharmaceutical research and development*. Adv Exp Med Biol. 543-61. 736. 2012.](https://pubmed.ncbi.nlm.nih.gov/22161351)

#### 40

[F. Langenbucher. *Linearization of dissolution rate curves by the Weibull distribution*. J Pharm Pharmacol.. 24(12). 979-81. 1972.](https://pubmed.ncbi.nlm.nih.gov/4146531)

#### 41

[D. G. Levitt. *Physiologically based pharmacokinetic modeling of arterial- antecubital vein concentration difference*. BMC Clinical Pharmacology. 4. 2. 2004.](https://pubmed.ncbi.nlm.nih.gov/15053829)

#### 42

[E. D. Lobo, R. J. Hansen, and J. P. Balthasar. *Antibody Pharmacokinetics and Pharmacodynamics*. J. Pharm. Sci.. 93(11). 2645-2668. 2004.](https://pubmed.ncbi.nlm.nih.gov/15389672)

#### 43

[A. Loidl-Stahlhofen, T. Hartmann, M. Schöttner, C. Röhring, H. Brodowsky, J. Schmitt, and J. Keldenich. *Multilamellar Liposomes and Solid- Supported Lipid Membranes (TRANSIL): Screening of Lipid-Water Partitioning Toward a High-Throughput Scale*. Pharmaceutical Research. 18. 1782-1788. 2001.](https://pubmed.ncbi.nlm.nih.gov/11785701)

#### 44

[G. Loizou, M. Spendiff, H.A. Barton, J. Bessems, F.Y. Bois, M.B. d'Yvoire, H. Buist, H.J. Clewell 3rd, B. Meek, U. Gundert-Remy, G. Goerlitz, and W. Schmitt. *Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment: the first steps*. Regulatory Toxicology and Pharmacology. 50(3). 400-11. 2008.](https://pubmed.ncbi.nlm.nih.gov/18331772)

#### 45

[K. Madsen, H.B. Nielsen, and O. Tingleff. *METHODS FOR NON- LINEAR LEAST SQUARES PROBLEMS*. 2nd Edition, April 2004.](http://www2.imm.dtu.dk/pubdb/views/edoc_download.php/3215/pdf/imm3215.pdf)

#### 46

[M. Meyer, S. Schneckener, B. Ludewig, L. Kuepfer, and J. Lippert. *Using expression data for quantification of active processes in physiologically- based pharmacokinetic modeling*. Drug Metab Dispos. 2012.](https://pubmed.ncbi.nlm.nih.gov/22293118)

#### 47

[John A. Nelder and R. Mead. *A simplex method for function minimization*. Computer Journal. 7. 308-313. 1965.](https://people.duke.edu/~hpgavin/cee201/Nelder+Mead-ComputerJournal-1965.pdf)

#### 48

[I. Nestorov. *Whole-body physiologically based pharmacokinetic models*. Exp Opin Drug Metab Toxicol. 3. 235-249. 2007.](https://pubmed.ncbi.nlm.nih.gov/17428153)

#### 49

[M. Nishimura, H. Yaguti, H. Yoshitsugu, S. Naito, and T. Satoh. *Tissue distribution of mRNA expression of human cytochrome P450 isoforms assessed by high-sensitivity real-time reverse transcription PCR*. Yakugaku Zasshi.. 123(5). 369-75. 2003.](https://pubmed.ncbi.nlm.nih.gov/12772594)

#### 50

[M. Nishimura and S. Naito. *Tissue-specific mRNA expression profiles of human ATP-binding cassette and solute carrier transporter superfamilies*. Drug Metab Pharmacokinet. 20(6). 452-77. 2005.](https://pubmed.ncbi.nlm.nih.gov/16415531)

#### 51

[M. Nishimura and S. Naito. *Tissue-specific mRNA expression profiles of human phase I metabolizing enzymes except for cytochrome P450 and phase II metabolizing enzymes*. Drug Metab Pharmacokinet. 21(5). 357-74. 2006.](https://pubmed.ncbi.nlm.nih.gov/17072089)

#### 52

[P. Poulin, K. Schoenlein, and F.P. Theil. *Prediction of adipose tissue: plasma partition coefficients for structurally unrelated drugs*. Journal of Pharmaceutical Sciences. 90(4). 436-47. 2001.](https://pubmed.ncbi.nlm.nih.gov/11170034)

#### 53

[P. Poulin and F. P. Theil. *A Priori Prediction of Tissue: Plasma Partition Coefficients of Drugs to Facilitate the Use of Physiologically-Based Pharmacokinetic Models in Drug Discovery*. Journal of Pharmaceutical Sciences. 89. 16-35. 2000.](https://pubmed.ncbi.nlm.nih.gov/10664535)

#### 54

[P. Poulin and F.P. Theil. *Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution*. Journal of Pharmaceutical Sciences. 91(1). 129-56. 2002.](https://pubmed.ncbi.nlm.nih.gov/11782904)

#### 55

[P. Poulin and F.P. Theil. *Prediction of pharmacokinetics prior to in vivo studies. II. Generic physiologically based pharmacokinetic models of drug disposition*. Journal of Pharmaceutical Sciences. 91(5). 1358-70. 2002.](https://pubmed.ncbi.nlm.nih.gov/11977112)

#### 56

[NJ. Proctor, GT. Tucker, and A. Rostami-Hodjegan. *Predicting drug clearance from recombinantly expressed CYPs: intersystem extrapolation factors.*. Xenobiotica. 34(2). 151-78. 2004.](https://pubmed.ncbi.nlm.nih.gov/14985145)

#### 57

[B. Rippe and B. Haraldsson. *Fluid and protein fluxes across small and large pores in the microvasculature. Application of two-pore equations*. Acta Physiol Scand.. 131(3). pp 411-28. 1987.](https://pubmed.ncbi.nlm.nih.gov/3321914)

#### 58

[B. Rippe and B. Haraldsson. *Transport of macromolecules across microvascular walls: the two-pore theory*. Am Physiological Soc.. 74. pp 163-219. 1994.](https://pubmed.ncbi.nlm.nih.gov/8295933)

#### 59

[T. Rodgers, D. Leahy, and M. Rowland. *Physiologically Based Pharmacokinetic Modeling 1: Predicting the Tissue Distribution of Moderate-to-Strong Bases*. Journal of Pharmaceutical Sciences. 94. 1259-1275. 2005.](https://pubmed.ncbi.nlm.nih.gov/15858854)

#### 60

[T. Rodgers, D. Leahy, and M. Rowland. *Tissue Distribution of Basic Drugs: Accounting for Enantiomeric, Compound and Regional Differences Amongst beta-Blocking Drugs in Rat*. Journal of Pharmaceutical Sciences. 94. 1237-1248. 2005.](https://pubmed.ncbi.nlm.nih.gov/15858851)

#### 61

[T. Rodgers and M. Rowland. *Physiologically Based Pharmacokinetic Modeling 2: Predicting the Tissue Distribution of Acids, Very Weak Bases, Neutrals and Zwitterions*. Journal of Pharmaceutical Sciences. 95. 1238-1257. 2006.](https://pubmed.ncbi.nlm.nih.gov/16639716)

#### 62

[T. Rodgers and M. Rowland. *Mechanistic Approaches to Volume of Distrubtion Predictions: Understanding the Processes*. Pharmaceutical Research. 24. 918-933. 2007.](https://pubmed.ncbi.nlm.nih.gov/17372687)

#### 63

[AD. Rodrigues. *Integrated cytochrome P450 reaction phenotyping: attempting to bridge the gap between cDNA-expressed cytochromes P450 and native human liver microsomes*. Biochem Pharmacol. 465-80. 57 (5). 1999.](https://pubmed.ncbi.nlm.nih.gov/9952310)

#### 64

[A. Rostami-Hodjegan and GT. Tucker. *Simulation and prediction of in vivo drug metabolism in human populations from in vitro data.*. Nat Rev Drug Discov. 6(2). 140-8. 2007.](https://pubmed.ncbi.nlm.nih.gov/17268485)

#### 65

M. Rowland and T.N. Tozer. *Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications*. 4th edition. D.B. Troy. Lippincott Williams and Wilkins. Philadelphia, PA 19106. pp. 199. 1984.

#### 66

[T. Sawamato, S. Haruta, Y. Kurosaki, K. Higaki, and T. Kimura. *Prediction of the Plasma Concentration Profiles of Orally Administered Drugs in Rats on the Basis of Gastrointestinal Transit Kinetics and Absorbability*. Journal of Pharmaceutical Pharmacology. 49. 450-457. 1997.](https://pubmed.ncbi.nlm.nih.gov/9232547)

#### 67

[J. Schlender. A report including the description of the physiology base of the Japanese population implemented in PK-Sim®.](https://github.com/Open-Systems-Pharmacology/OSPSuite.Documentation/blob/master/Japanese_Population/Report.md)

#### 68

[W. Schmitt. *General approach for the calculation of tissue to plasma partition coefficients*. Toxicology In Vitro. 22(2). 457-67. 2008.](https://pubmed.ncbi.nlm.nih.gov/17981004)

#### 69

[W. Schmitt and S. Willmann. *Physiology-based pharmacokinetic modeling: ready to be used*. Drug Discov Today. 2. 125-132. 2005.](https://pubmed.ncbi.nlm.nih.gov/24981765)

#### 70

[L. F. Shampine. *Solving ODEs and DDEs with residual control*. Appl. Num. Math.. 52. 113-127. 2005.](https://www.sciencedirect.com/science/article/abs/pii/S0168927404001187)

#### 71

[P. Sidhu, H. T. Peng, B. Cheung, and A. Edginton. *Simulation of differential drug pharmacokinetics under heat and exercise stress using a physiologically based pharmacokinetic modeling approach*. Can J Physiol Pharmacol. 365-82. 89(5). 2011.](https://pubmed.ncbi.nlm.nih.gov/21627485)

#### 72

[R.B. Silvermann. *Mechanism-based enzyme inhibitors*. Methods in Enzymology. 249. 1995.](https://pubmed.ncbi.nlm.nih.gov/7791614)

#### 73

[A. Strougo, T. Eissing, A. Yassen, S. Willmann, M. Danhof, and J. Freijer. *First dose in children: physiological insights into pharmacokinetic scaling approaches and their implications in paediatric drug development*. J Pharmacokinet Pharmacodyn. 2012.](https://pubmed.ncbi.nlm.nih.gov/22311388)

#### 74

G. Tanaka and H. Kawamura. *Anatomical and physiological characteristics for Asian reference man: Male and female of different ages: Tanaka model*. Division of Radioecology. National Institute of Radiological Sciences. Hitachinaka 311-12 Japan. Report Number NIRS-M-115. 1996.

#### 75

[A. Terenji, S. Willmann, J. Osterholz, P. Hering, and H. J. Schwarzmaier. *Measurement of the coagulation dynamics of bovine liver using the modified microscopic Beer-Lambert law*. Lasers Surg Med. 365-70. 36(5). 2005.](https://pubmed.ncbi.nlm.nih.gov/15825206)

#### 76

[F. P. Theil, T. W. Guentert, S. Haddad, and P. Poulin. *Utility of Physiologically Based Pharmacokinetic Models to Drug Development and Rational Drug Discovery Candidate Selection*. Toxicology Letters. 138. 29-49. 2003.](https://pubmed.ncbi.nlm.nih.gov/12559691)

#### 77

[K. Thelen and J.B. Dressman. *Cytochrome P450-mediated metabolism in the human gut wall*. Journal of Pharmacokinetics and Pharmacodynamics. 61(5). 541-58. 2009.](https://pubmed.ncbi.nlm.nih.gov/19405992)

#### 78

[K. Thelen, E. Jantratid, J. B. Dressman, J. Lippert, and S. Willmann. *Analysis of nifedipine absorption from soft gelatin capsules using PBPK modeling and biorelevant dissolution testing*. J Pharm Sci. 2899-904. 99(6). 2010.](https://pubmed.ncbi.nlm.nih.gov/20014280)

#### 79

[K. Thelen, K. Coboeken, S. Willmann, R. Burghaus, J. B. Dressman, and J. Lippert. *Evolution of a detailed physiological model to simulate the gastrointestinal transit and absorption process in humans, part 1: oral solutions*. J Pharm Sci. 5324-45. 100(12). 2011.](https://pubmed.ncbi.nlm.nih.gov/21993815)

#### 80

[K. Thelen, K. Coboeken, S. Willmann, J. B. Dressman, and J. Lippert. *Evolution of a detailed physiological model to simulate the gastrointestinal transit and absorption process in humans, part II: extension to describe performance of solid dosage forms*. J Pharm Sci. 1267-80. 101(3). 2012.](https://pubmed.ncbi.nlm.nih.gov/22125236)

#### 81

[K. Thelen, K. Coboeken, Y. Jia, J.B. Dressman, S. Willmann. *Dynamically simulating the effect of food on gastric emptying using a detailed physiological model for gastrointestinal transit and absorption*. PAGE meeting 2012. Venice, Italy. 2012.](https://www.page-meeting.org/default.asp?abstract=2355)

#### 82

Third National Health and Nutrition Examination Survey, (NHANES III). 1997. National Center for Health Statistics Hyattsville, MD 20782 <http://www.cdc.gov/nchs/nhanes.htm>

#### 83

Expressed Sequence Tags (EST) from UniGene. 2010. National Center for Biotechnology Information (NCBI) <https://ftp.ncbi.nlm.nih.gov/repository/UniGene/>

#### 84

[Annals of the ICRP. Basic Anatomical and Physiological Data for Use in Radiological Protection: Reference Values. J. Valentin. Vol. 32 (3-4). 2002.](https://pubmed.ncbi.nlm.nih.gov/14506981)

#### 85

[P. H. van der Graaf and N. Benson. *Systems pharmacology: bridging systems biology and pharmacokineticspharmacodynamics (PKPD) in drug discovery and development*. Pharm Res. 1460-4. 28(7). 2011.](https://pubmed.ncbi.nlm.nih.gov/21560018)

#### 86

[B. van Ommen, J. de Jongh, J. van de Sandt, B. Blaauboer, E. Hissink, J. Bogaards, and P. Bladeren. *Computer-aided Biokinetic Modelling Combined with In Vitro Data*. Toxicology In Vitro. 9. 537-542. 1995.](https://pubmed.ncbi.nlm.nih.gov/20650125)

#### 87

[M. Vossen, M. Sevestre, C. Niederalt, I. J. Jang, S. Willmann, and A. N. Edginton. *Dynamically simulating the interaction of midazolam and the CYP3A4 inhibitor itraconazole using individual coupled whole-body physiologically-based pharmacokinetic (WB-PBPK) models*. Theor Biol Med Model. 13. 4. 2007.](https://pubmed.ncbi.nlm.nih.gov/17386084)

#### 88

[W. Wang, E. Q. Wang, and J.P. Balthasar. *Monoclonal Antibody Pharmacokinetics and Pharmacodynamics*. Clin Pharmacol Ther.. 548-58. 84(5). 2008.](https://pubmed.ncbi.nlm.nih.gov/18784655)

#### 89

[O. Weber, S. Willmann, H. Bischoff, V. Li, A. Vakalopoulos, K. Lustig, F. T. Hafner, R. Heinig, C. Schmeck, and K. Buehner. *Prediction of a potentially effective dose in humans for BAY 60-5521, a potent inhibitor of cholesteryl ester transfer protein (CETP) by allometric species scaling and combined pharmacodynamic and physiologically-based pharmacokinetic modelling*. Br J Clin Pharmacol. 219-31. 73(2). 2012.](https://pubmed.ncbi.nlm.nih.gov/21762205)

#### 90

[S. Willmann, H. J. Schwarzmaier, A. Terenji, I. V. Yaroslavsky, and P. Hering. *Quantitative microspectrophotometry in turbid media*. Appl Opt. 4904-13. 38(22). 1999.](https://pubmed.ncbi.nlm.nih.gov/18323981)

#### 91

[S. Willmann, A. Terenji, H. Busse, I. V. Yaroslavsky, A. N. Yaroslavsky, H. J. Schwarzmaier, and P. Hering. *Scattering delay time of Mie scatterers determined from steady-state and time-resolved optical spectroscopy*. J Opt Soc Am A Opt Image Sci Vis. 745-9. 17(4). 2000.](https://pubmed.ncbi.nlm.nih.gov/10757182)

#### 92

[S. Willmann, J. Lippert, M. Sevestre, J. Solodenko, F. Fois, and W. Schmitt. PK-Sim®: A physiologically based pharmacokinetic 'whole-body' model. Biosilico. 1. 121-124. 2003.](https://www.sciencedirect.com/science/article/abs/pii/S1478538203023424)

#### 93

[S. Willmann, W. Schmitt, J. Keldenich, and J. B. Dressman. *A Physiologic Model for Simulating Gastrointestinal Flow and Drug Absorption in Rats*. Pharmaceutical Research. 20. 1766-1771. 2003.](https://pubmed.ncbi.nlm.nih.gov/14661920)

#### 94

[S. Willmann, A. Terenji, J. Osterholz, J. Meister, P. Hering, and H.J. Schwarzmaier. *Small-volume frequency-domain oximetry: phantom experiments and first in vivo results*. J Biomed Opt. 618-28. 8(4). 2003.](https://pubmed.ncbi.nlm.nih.gov/14563199)

#### 95

[S. Willmann, W. Schmitt, J. Keldenich, J. Lippert, and J. B. Dressman. *A Physiological Model for the Estimation of Fraction Dose Absorbed in Humans*. Journal of Medical Chemistry. 47. 4022-4031. 2004.](https://pubmed.ncbi.nlm.nih.gov/15267240)

#### 96

[S. Willmann, J. Lippert, and W. Schmitt. *From physicochemistry to absorption and distribution: predictive mechanistic modelling and computational tools*. Expert Opinion on Drug Metabolism and Toxicology. 1. 159-168. 2005.](https://pubmed.ncbi.nlm.nih.gov/16922658)

#### 97

[S. Willmann, K. Hoehn, A. N. Edginton, M. Sevestre, J. Solodenko, W. Weiss, J. Lippert, and W. Schmitt. *Development of a physiologically-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs*. Journal of Pharmacokinetics and Pharmacodynamics. 34(3). 401-431. 2007.](https://pubmed.ncbi.nlm.nih.gov/17431751)

#### 98

[S. Willmann, A.N. Edginton, and J.B. Dressman. *Development and validation of a physiology-based model for the prediction of oral absorption in monkeys*. Pharmaceutical Research. 24(7). 1275-82. 2007.](https://pubmed.ncbi.nlm.nih.gov/17373575)

#### 99

[S. Willmann, A.N. Edginton, M. Kleine-Besten, E. Jantratid, K. Thelen, and J.B. Dressman. *Whole-Body Physiologically-Based Pharmacokinetic Population Modelling of Oral Drug Administration: Inter-Individual Variability of Cimetidine Absorption*. Journal of Pharmacokinetics and Pharmacodynamics. 61. 891-9. 2009.](https://pubmed.ncbi.nlm.nih.gov/19589231)

#### 100

[S. Willmann, A.N. Edginton, K. Coboeken, G. Ahr, and J. Lippert. *Risk to the Breast-Fed Neonate From Codeine Treatment to the Mother: A Quantitative Mechanistic Modeling Study*. Clinical Pharmacology and Therapeutics. advance online publication. 2009.](https://pubmed.ncbi.nlm.nih.gov/19710640)

#### 101

[S. Willmann. *The in silico Child. Can computer simulations replace clinical pharmacokinetic studies?*. Original: Das In-silico-Child. Konnen Computer-Simulationen klinisch-pharmakokinetische Studien ersetzen?. Pharm Unserer Zeit. 62-7. 38(1). 2009.](https://pubmed.ncbi.nlm.nih.gov/19132649)

#### 102

[S. Willmann, K. Thelen, C. Becker, J. B. Dressman, and J. Lippert. *Mechanism-based prediction of particle size-dependent dissolution and absorption: cilostazol pharmacokinetics in dogs*. Eur J Pharm Biopharm. 83-94. 76(1). 2010.](https://pubmed.ncbi.nlm.nih.gov/20554023)

#### 103

Y. Wu and F. Kesisoglou. *Immediate Release Oral Dosage Forms: Formulation Screening in the Pharmaceutical Industry*. in: Oral Drug Absorption: Prediction and Assessment. J. J. Dressman. C. Reppas. Informa Healthcare. New York, USA. pp. 323. 2009.

#### 104

[J. Yang, M. Jamei, and K. Rowland Yeo. *Theoretical assessment of a new experimental protocol for determining kinetic values describing mechanism (time)-based enzyme inhibition* . European Journal in Pharmaceutical Sciences. 31. 2007.](https://pubmed.ncbi.nlm.nih.gov/17512176)

#### 105

[H. Zischka, C. J. Gloeckner, C. Klein, S. Willmann, M. Swiatek-de Lange, and M. Ueffing. *Improved mass spectrometric identification of gel- separated hydrophobic membrane proteins after sodium dodecyl sulfate removal by ion-pair extraction*. Proteomics. 3776-82. 4(12). 2004.](https://pubmed.ncbi.nlm.nih.gov/15540170)

#### 106

[Hanke N, Frechen S, Moj D, Britz H, Eissing T, Wendl T, Lehr T. *PBPK models for CYP3A4 and P‐gp DDI prediction: a modeling network of rifampicin, itraconazole, clarithromycin, midazolam, alfentanil and digoxin.*](https://www.ncbi.nlm.nih.gov/pubmed/30091221)

#### 107

[Dallmann A, Ince I, Solodenko J, et al. Physiologically Based Pharmacokinetic Modeling of Renally Cleared Drugs in Pregnant Women. Clin Pharmacokinet. 2017;56(12):1525-1541. doi:10.1007/s40262-017-0538-0](https://pubmed.ncbi.nlm.nih.gov/28391404)

#### 108

[Dallmann A, Ince I, Meyer M, Willmann S, Eissing T, Hempel G. Gestation-Specific Changes in the Anatomy and Physiology of Healthy Pregnant Women: An Extended Repository of Model Parameters for Physiologically Based Pharmacokinetic Modeling in Pregnancy. Clin Pharmacokinet. 2017;56(11):1303-1330. doi:10.1007/s40262-017-0539-z](https://pubmed.ncbi.nlm.nih.gov/28401479)

#### 109

[Dallmann A, Ince I, Coboeken K, Eissing T, Hempel G. A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways. Clin Pharmacokinet. 2018;57(6):749-768. doi:10.1007/s40262-017-0594-5](https://pubmed.ncbi.nlm.nih.gov/28924743)

#### 110

[Dallmann A, Solodenko J, Ince I, Eissing T. Applied Concepts in PBPK Modeling: How to Extend an Open Systems Pharmacology Model to the Special Population of Pregnant Women. CPT Pharmacometrics Syst Pharmacol. 2018;7(7):419-431. doi:10.1002/psp4.12300](https://pubmed.ncbi.nlm.nih.gov/29569837)

#### 111

[Claassen K, Thelen K, Coboeken K, et al. Development of a Physiologically-Based Pharmacokinetic Model for Preterm Neonates: Evaluation with In Vivo Data. *Curr Pharm Des*. 2015;21(39):5688-5698. doi:10.2174/1381612821666150901110533](https://pubmed.ncbi.nlm.nih.gov/26323410)

#### 112

[Mavroudis PD, Hermes HE, Teutonico D, Preuss TG, Schneckener S. Development and validation of a physiology-based model for the prediction of pharmacokinetics/toxicokinetics in rabbits. *PLoS One*. 2018;13(3):e0194294. Published 2018 Mar 21. doi:10.1371/journal.pone.0194294](https://pubmed.ncbi.nlm.nih.gov/29561908)

#### 113

[Schlender JF, Meyer M, Thelen K, et al. Development of a Whole-Body Physiologically Based Pharmacokinetic Approach to Assess the Pharmacokinetics of Drugs in Elderly Individuals. *Clin Pharmacokinet*. 2016;55(12):1573-1589. doi:10.1007/s40262-016-0422-3](https://pubmed.ncbi.nlm.nih.gov/27351180/)

#### 114

[Niederalt C, Kuepfer L, Solodenko J, et al. A generic whole body physiologically based pharmacokinetic model for therapeutic proteins in PK-Sim. *J Pharmacokinet Pharmacodyn*. 2018;45(2):235-257. doi:10.1007/s10928-017-9559-4](https://pubmed.ncbi.nlm.nih.gov/29234936)

#### 115

[Lippert J, Burghaus R, Edginton A, et al. Open Systems Pharmacology Community-An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences. *CPT Pharmacometrics Syst Pharmacol*. 2019;8(12):878-882. doi:10.1002/psp4.12473](https://pubmed.ncbi.nlm.nih.gov/31671256)

#### 116

[Kuepfer L, Niederalt C, Wendl T, et al. Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model. *CPT Pharmacometrics Syst Pharmacol*. 2016;5(10):516-531. doi:10.1002/psp4.12134](https://pubmed.ncbi.nlm.nih.gov/27653238)

#### 117

[EFPIA MID3 Workgroup, Marshall SF, Burghaus R, et al. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation. *CPT Pharmacometrics Syst Pharmacol*. 2016;5(3):93-122. doi:10.1002/psp4.12049](https://pubmed.ncbi.nlm.nih.gov/27069774)

#### 118

[Schneckener S, Preuss TG, Kuepfer L, Witt J. A workflow to build PBTK models for novel species. *Arch Toxicol*. 2020;94(11):3847-3860. doi:10.1007/s00204-020-02922-z](https://pubmed.ncbi.nlm.nih.gov/33033842)

#### 119

[Ince I, Solodenko J, Frechen S, et al. Predictive Pediatric Modeling and Simulation Using Ontogeny Information. *J Clin Pharmacol*. 2019;59 Suppl 1:S95-S103. doi:10.1002/jcph.1497](https://pubmed.ncbi.nlm.nih.gov/31502689)

#### 120

[Sjögren E, Tarning J, Barnes KI, Jonsson EN. A Physiologically-Based Pharmacokinetic Framework for Prediction of Drug Exposure in Malnourished Children. *Pharmaceutics*. 2021;13(2):204. Published 2021 Feb 2. doi:10.3390/pharmaceutics13020204](https://pubmed.ncbi.nlm.nih.gov/33540928)

#### 121

[Frechen S, Solodenko J, Wendl T, et al. A generic framework for the physiologically-based pharmacokinetic platform qualification of PK-Sim and its application to predicting cytochrome P450 3A4-mediated drug-drug interactions. CPT Pharmacometrics Syst Pharmacol. 2021;10(6):633-644. doi:10.1002/psp4.12636](https://pubmed.ncbi.nlm.nih.gov/33946131)

#### 122

[Paul R.V. Malik, Cindy H.T. Yeung, Shams Ismaeil, Urooj Advani, Sebastian Djie, Andrea N. Edginton. A Physiological Approach to Pharmacokinetics in Chronic Kidney Disease](https://accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.1713)