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.​
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.​
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.​
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.​
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.​
7
​P. Costa and J. M. Sousa Lobo. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 13(2). 123-33. 2001.​
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.​
10
​J.B. Dressman, K. Thelen, and E. Jantratid. Towards Quantitative Prediction of Oral Drug Absorption. Clinical Pharmacokinetics. 47(10). 655-67. 2008.​
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.​
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.​
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.​
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.​
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.​
16
​A. N. Edginton and G. Joshi. Have physiologically-based pharmacokinetic models delivered?. Expert Opin Drug Metab Toxicol. 929-34. 7(8). 2011.​
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.​
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.​
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.​
20
​C.T. Ekstrom (Editor). Introduction to Statistical Data Analysis for the Life Sciences, Second Edition. CRC Press. 2014.​
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.​
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.​
23
​L. Fahrmeir, T. Kneib, and S. Lang. Regression Modelle, Methoden und Anwendungen. Springer Verlag. 2009.​
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.​
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.​
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.​
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.​
29
​R. Gebhardt. Metabolic zonation of the liver: Regulation and implications for liver function. Pharmacol. Ther.. 53(3). 275-354. 1992.​
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.​
31
​H. W. Haagard. The Absorption, Distribution and Elimination of Ethyl Ether. The Journal of Biological Chemistry. 59. 753-770. 1924.​
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.​
33
​W. L. Hayton. Maturation and Growth of Renal Function: Dosing Renally Cleared Drugs in Children. AAPS PharmSci. 2(1). E3. 2002.​
34
​P. Holliger and P. J. Hudson. Engineered antibody fragments and the rise of single domains. Nat Biotechnol.. 23(9). 1126-36. 2005.​
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.​
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.​
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.​
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.​
39
​L. Kuepfer, J. Lippert, and T. Eissing. Multiscale mechanistic modeling in pharmaceutical research and development. Adv Exp Med Biol. 543-61. 736. 2012.​
40
​F. Langenbucher. Linearization of dissolution rate curves by the Weibull distribution. J Pharm Pharmacol.. 24(12). 979-81. 1972.​
41
​D. G. Levitt. Physiologically based pharmacokinetic modeling of arterial- antecubital vein concentration difference. BMC Clinical Pharmacology. 4. 2. 2004.​
42
​E. D. Lobo, R. J. Hansen, and J. P. Balthasar. Antibody Pharmacokinetics and Pharmacodynamics. J. Pharm. Sci.. 93(11). 2645-2668. 2004.​
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.​
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.​
45
​K. Madsen, H.B. Nielsen, and O. Tingleff. METHODS FOR NON- LINEAR LEAST SQUARES PROBLEMS. 2nd Edition, April 2004.​
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.​
47
​John A. Nelder and R. Mead. A simplex method for function minimization. Computer Journal. 7. 308-313. 1965.​
48
​I. Nestorov. Whole-body physiologically based pharmacokinetic models. Exp Opin Drug Metab Toxicol. 3. 235-249. 2007.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
58
​B. Rippe and B. Haraldsson. Transport of macromolecules across microvascular walls: the two-pore theory. Am Physiological Soc.. 74. pp 163-219. 1994.​
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.​
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.​
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.​
62
​T. Rodgers and M. Rowland. Mechanistic Approaches to Volume of Distrubtion Predictions: Understanding the Processes. Pharmaceutical Research. 24. 918-933. 2007.​
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.​
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.​
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.​
67
​J. Schlender. A report including the description of the physiology base of the Japanese population implemented in PK-Sim®.​
68
​W. Schmitt. General approach for the calculation of tissue to plasma partition coefficients. Toxicology In Vitro. 22(2). 457-67. 2008.​
69
​W. Schmitt and S. Willmann. Physiology-based pharmacokinetic modeling: ready to be used. Drug Discov Today. 2. 125-132. 2005.​
70
​L. F. Shampine. Solving ODEs and DDEs with residual control. Appl. Num. Math.. 52. 113-127. 2005.​
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.​
72
​R.B. Silvermann. Mechanism-based enzyme inhibitors. Methods in Enzymology. 249. 1995.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
82
​Third National Health and Nutrition Examination Survey, (NHANES III). 1997. National Center for Health Statistics Hyattsville, MD 20782​
83
​Expressed Sequence Tags (EST) from UniGene. 2010. National Center for Biotechnology Information (NCBI)​
84
​Annals of the ICRP. Basic Anatomical and Physiological Data for Use in Radiological Protection: Reference Values. J. Valentin. Vol. 32 (3-4). 2002.​
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.​
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.​
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.​
88
​W. Wang, E. Q. Wang, and J.P. Balthasar. Monoclonal Antibody Pharmacokinetics and Pharmacodynamics. Clin Pharmacol Ther.. 548-58. 84(5). 2008.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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.​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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​
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