Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling
Allometric scaling can be used for the extrapolation of pharmacokinetic parameters from adults to children. The objective of this study was to predict clearance of therapeutic proteins (monoclonal and polyclonal antibodies and non-antibody proteins) allometrically in preterm neonates to adolescents....
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-08-01
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| Series: | Antibodies |
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| Online Access: | https://www.mdpi.com/2073-4468/9/3/40 |
| _version_ | 1827711552765034496 |
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| author | Iftekhar Mahmood |
| author_facet | Iftekhar Mahmood |
| author_sort | Iftekhar Mahmood |
| collection | DOAJ |
| description | Allometric scaling can be used for the extrapolation of pharmacokinetic parameters from adults to children. The objective of this study was to predict clearance of therapeutic proteins (monoclonal and polyclonal antibodies and non-antibody proteins) allometrically in preterm neonates to adolescents. There were 13 monoclonal antibodies, seven polyclonal antibodies, and nine therapeutic proteins (non-antibodies) in the study. The clearance of therapeutic proteins was predicted using the age dependent exponents (ADE) model and then compared with the observed clearance values. There were in total 29 therapeutic proteins in this study with 75 observations. The number of observations with ≤30%, ≤50%, and >50% prediction error was 60 (80%), 72 (96%), and 3 (4%), respectively. Overall, the predicted clearance values of therapeutic proteins in children was good. The allometric method proposed in this manuscript can be used to select first-in-pediatric dose of therapeutic proteins in pediatric clinical trials. |
| first_indexed | 2024-03-10T17:56:10Z |
| format | Article |
| id | doaj.art-9f96fe9db3e840ec85cd5e3bf904d729 |
| institution | Directory Open Access Journal |
| issn | 2073-4468 |
| language | English |
| last_indexed | 2024-03-10T17:56:10Z |
| publishDate | 2020-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Antibodies |
| spelling | doaj.art-9f96fe9db3e840ec85cd5e3bf904d7292023-11-20T09:10:55ZengMDPI AGAntibodies2073-44682020-08-01934010.3390/antib9030040Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric ScalingIftekhar Mahmood0Mahmood Clinical Pharmacology, Consultancy, LLC, 1709, Piccard Dr, Rockville, MD 20850, USAAllometric scaling can be used for the extrapolation of pharmacokinetic parameters from adults to children. The objective of this study was to predict clearance of therapeutic proteins (monoclonal and polyclonal antibodies and non-antibody proteins) allometrically in preterm neonates to adolescents. There were 13 monoclonal antibodies, seven polyclonal antibodies, and nine therapeutic proteins (non-antibodies) in the study. The clearance of therapeutic proteins was predicted using the age dependent exponents (ADE) model and then compared with the observed clearance values. There were in total 29 therapeutic proteins in this study with 75 observations. The number of observations with ≤30%, ≤50%, and >50% prediction error was 60 (80%), 72 (96%), and 3 (4%), respectively. Overall, the predicted clearance values of therapeutic proteins in children was good. The allometric method proposed in this manuscript can be used to select first-in-pediatric dose of therapeutic proteins in pediatric clinical trials.https://www.mdpi.com/2073-4468/9/3/40allometrychildrenclearancetherapeutic proteinsmonoclonal antibodiespolyclonal antibodies |
| spellingShingle | Iftekhar Mahmood Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling Antibodies allometry children clearance therapeutic proteins monoclonal antibodies polyclonal antibodies |
| title | Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling |
| title_full | Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling |
| title_fullStr | Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling |
| title_full_unstemmed | Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling |
| title_short | Prediction of Clearance of Monoclonal and Polyclonal Antibodies and Non-Antibody Proteins in Children: Application of Allometric Scaling |
| title_sort | prediction of clearance of monoclonal and polyclonal antibodies and non antibody proteins in children application of allometric scaling |
| topic | allometry children clearance therapeutic proteins monoclonal antibodies polyclonal antibodies |
| url | https://www.mdpi.com/2073-4468/9/3/40 |
| work_keys_str_mv | AT iftekharmahmood predictionofclearanceofmonoclonalandpolyclonalantibodiesandnonantibodyproteinsinchildrenapplicationofallometricscaling |