ADME and Translational Pharmacokinetics / Pharmacodynamics by Honghui Zhou, Frank-Peter Theil

By Honghui Zhou, Frank-Peter Theil

With an emphasis at the basic and sensible elements of ADME for healing proteins, this booklet is helping readers strategize, plan and enforce translational study for biologic drugs.

• Details state-of-the-art ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs
• Combines theoretical with sensible features of ADME in biologic drug discovery and improvement and compares innovator biologics with biosimilar biologics and small molecules with biologics,  giving a lessons-learned viewpoint
• Includes case experiences approximately leveraging ADME to enhance biologics drug improvement for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines
• Presents regulatory expectancies and views for constructing biologic medicines in united states, european, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in vital websites of motion reminiscent of tumors and the brain

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Extra resources for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development

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Principles and applications of LC‐MS in new drug discovery. Drug Discov Today 2005;10:1357–1367. [25] Castro‐Perez J, Plumb R, Granger JH, Beattie L, Joncour K, Wright A. Increasing throughput and information content for in vitro drug metabolism experiments using ultra‐ performance liquid chromatography coupled to a quadrupole time‐of‐flight mass spectrometer. Rapid Commun Mass Spectrom 2005;19:843–848. [26] Korfmacher WA. Use of mass spectrometry for drug metabolism studies. Curr Drug Metab 2006;7:455–563.

N‐terminal glutamine (Gln) residues, frequently found on heavy chains, are liable to cyclize to form pyroglutamate, by the free NH2 group reacting with the side chain [57]. This occurs naturally in antibodies but the reaction may not go to completion and any heterogeneity in preparations of recombinant antibodies is undesirable. A potential solution is to replace the Gln with glutamate (Glu), also a common N‐terminal residue on antibody heavy chains. Clipping of the C‐terminal lysine (Lys) residues in both human IgG1 and IgG4 can also occur and gives rise to a difference in charge [57].

Serum TRX1 concentration and total and free CD4 levels were measured and fitted into the model ­simultaneously to account for the effect of PD on PK. This mechanism‐based PK/PD model was later used to simulate PK/PD-time profiles after different dosing regi­ mens to help guide the dose selection in future clinical studies. For LM drugs against soluble targets, the impact of target binding on drug PK may not be as apparent, depending on whether the elimination rate for drug–target complex is similar to that of the free drug [80, 81].

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