Contrasting toxicokinetic evaluations and interspecies pharmacokinetic scaling approaches for small molecules and biologics: applicability to biosimilar development

Quantitative Prediction of Human Pharmacokinetics for Monoclonal Antibodies

(2011) Jennifer Q. Dong et al.   CLINICAL PHARMACOKINETICS

Prediction of Human Plasma Concentration-time Profiles of Monoclonal Antibodies from Monkey Data by a Species-invariant Time Method

(2011) Masataka Oitate et al.   Drug Metabolism and Pharmacokinetics

Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data

(2011) Rong Deng et al.   mAbs

Interspecies scaling and prediction of human clearance: comparison of small- and macro-molecule drugs

(2011) Yeamin Huh et al.   XENOBIOTICA

A Comparison of Pharmacokinetics between Humans and Monkeys

(2009) T. Akabane et al.   DRUG METABOLISM AND DISPOSITION

Physiologically based pharmacokinetics (PBPK)

(2009) Pascal Espié et al.   DRUG METABOLISM REVIEWS

Pharmacokinetic allometric scaling of coagulation factors and tissue-type plasminogen activators

(2009) I. MAHMOOD   HAEMOPHILIA

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

(2009) Jie Ling et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetic Allometric Scaling of Antibodies: Application to the First-In-Human Dose Estimation

(2009) Iftekhar Mahmood   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically-Based PK/PD Modelling of Therapeutic Macromolecules

(2009) Peter Thygesen et al.   PHARMACEUTICAL RESEARCH

Role of Fixed Coefficients and Exponents in the Prediction of Human Drug Clearance: How Accurate are the Predictions from One or Two Species?

(2008) Iftekhar Mahmood   JOURNAL OF PHARMACEUTICAL SCIENCES