By Rodney J. Y. Ho

ISBN-10: 0471206903

ISBN-13: 9780471206903

ISBN-10: 0471398462

ISBN-13: 9780471398462

Biotechnology and Biopharmaceuticals: remodeling Proteins and Genes into medicines defines biotechnology from the viewpoint of prescribed drugs. the 1st part makes a speciality of the method of reworking a biologic macromolecule right into a healing agent, whereas the second one part presents a short assessment of every classification of macromolecule with appreciate to physiological position and medical program. extra element can be supplied within the moment part for every FDA licensed, recombinantly derived biopharmaceutical for every class of macromolecule. the ultimate part seems to be to the longer term and the recent advances that may increase our skill to improve new macromolecules into powerful biopharmaceuticals. This final part discusses a variety of drug supply recommendations whereas additionally describing gene and phone remedy thoughts.

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Clin. Pharmacol. 40 : 803–814. , and M. Danhof. 1997. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The ‘wooden shoe’ paradigm. Clin. Pharmacokinet. 32 : 259–267. M. Persky, G. Hochhaus, and B. Meibohm. 2004. Pharmacokinetic aspects of biotechnology products. J. Pharm. Sci. 93 : 2184–2204. Levy, G. 1994. Pharmacologic targetmediated drug disposition. Clin. Pharmacol. Ther. 56 : 248–252. , C. Berg, R. Nassr, and K. Pang. 2003. The further evolution of biotech.

2000. Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans. J. Clin. Pharmacol. 40 : 803–814. , and M. Danhof. 1997. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The ‘wooden shoe’ paradigm. Clin. Pharmacokinet. 32 : 259–267. M. Persky, G. Hochhaus, and B. Meibohm. 2004. Pharmacokinetic aspects of biotechnology products. J. Pharm. Sci. 93 : 2184–2204. Levy, G. 1994.

Furthermore, the steady-state volume of distribution (Vss) is usually no more than twice the initial volume of distribution, or approximately 14–20 L [13, 37, 43]. 9 L) [52]. 0558 L/kg after an IV administration to healthy volunteers [53]. 0621 L/kg after an IV administration in patients undergoing dialysis [54], and distribution of thrombopoietin has also been reported to be limited to the plasma volume (~3 L) [55]. Active tissue uptake and binding to intra- and extravascular proteins, however, can substantially increase the volume of distribution of peptide and protein drugs, as for example observed with atrial natriuretic peptide (ANP) [56].

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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs by Rodney J. Y. Ho


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