By Bernd Meibohm
This primary ever insurance of the pharmacokinetic and pharmacodynamic features of biopharmaceuticals meets the necessity for a complete booklet during this box. It spans all subject matters from lead identity correct as much as final-stage scientific trials.
Following an creation to the function of PK and PD within the improvement of biotech medicinal drugs, the ebook is going directly to conceal the fundamentals, together with the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, in addition to viral and non-viral gene supply vectors. the second one part discusses such demanding situations and possibilities as pulmonary supply of proteins and peptides, and the supply of oligonucleotides. the ultimate part considers the mixing of PK and PD techniques into the biotech drug improvement plan, taking as case reviews the preclinical and medical drug improvement of tasidotin, in addition to the examples of cetuximab and pegfilgrastim.
the result's important analyzing for all pharmaceutical researchers.Content:
Chapter 1 The function of Pharmacokinetics and Pharmacodynamics within the improvement of Biotech medications (pages 1–13): Prof. Dr. Bernd Meibohm
Chapter 2 Pharmacokinetics of Peptides and Proteins (pages 15–43): Lisa Tang and Prof. Dr. Bernd Meibohm
Chapter three Pharmacokinetics of Monoclonal Antibodies (pages 45–91): Katharina Kuester and Charlotte Kloft
Chapter four Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides (pages 93–120): Rosie Z. Yu, Richard S. Geary and Arthur A. Levin
Chapter five Pharmacokinetics of Viral and Non?Viral Gene supply Vectors (pages 121–144): Martin Meyer, Gururaj Rao, Ke Ren and Jeffrey Hughes
Chapter 6 Bioanalytical equipment Used for Pharmacokinetic reviews of Biotech Macromolecule medicines: matters, Assay methods, and boundaries (pages 145–180): Jean W. Lee
Chapter 7 barriers of Noncompartmental Pharmacokinetic research of Biotech medicinal drugs (pages 181–188): Arthur B. Straughn
Chapter eight Bioequivalence of Biologics (pages 189–208): Jeffrey S. Barrett
Chapter nine Biopharmaceutical demanding situations: Pulmonary supply of Proteins and Peptides (pages 209–242): Kun Cheng and Ram I. Mahato
Chapter 10 Biopharmaceutical demanding situations: supply of Oligonucleotides (pages 243–269): Lloyd G. Tillman and Gregory E. Hardee
Chapter eleven Custom?Tailored Pharmacokinetics and Pharmacodynamics through Chemical ameliorations of Biotech medicines (pages 271–294): Francesco M. Veronese and Paolo Caliceti
Chapter 12 Exposure–Response Relationships for healing Biologic items (pages 295–327): Mohammad Tabrizi and Lorin okay. Roskos
Chapter thirteen Preclinical and medical Drug improvement of Tasidotin, a Depsi?Pentapeptide Oncolytic Agent (pages 329–351): Peter L. Bonate, Larry Arthaud and Katherine Stephenson
Chapter 14 scientific Drug improvement of Cetuximab, a Monoclonal Antibody (pages 353–371): Arno Nolting, Floyd E. Fox and Andreas Kovar
Chapter 15 Integration of Pharmacokinetics and Pharmacodynamics into the Drug improvement of Pegfilgrastim, a Pegylated Protein (pages 373–393): Bing?Bing Yang
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Sample text
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