Academic Journal
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report
| Τίτλος: | Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report |
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| Συγγραφείς: | Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E. Polli, Gregory Rullo |
| Πηγή: | Mol Pharm |
| Στοιχεία εκδότη: | American Chemical Society (ACS), 2024. |
| Έτος έκδοσης: | 2024 |
| Θεματικοί όροι: | Drug Industry, Therapeutic Equivalency, Pharmaceutical Preparations, Humans, Models, Biological, United States, Biopharmaceutics |
| Περιγραφή: | Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration. |
| Τύπος εγγράφου: | Article Other literature type |
| Γλώσσα: | English |
| ISSN: | 1543-8392 1543-8384 |
| DOI: | 10.1021/acs.molpharmaceut.4c00202 |
| Σύνδεσμος πρόσβασης: | https://pubmed.ncbi.nlm.nih.gov/38600804 |
| Rights: | CC BY NC ND |
| Αριθμός Καταχώρησης: | edsair.doi.dedup.....b3eb6f42c2ba08c4a95754031b7d9a1f |
| Βάση Δεδομένων: | OpenAIRE |
| ISSN: | 15438392 15438384 |
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| DOI: | 10.1021/acs.molpharmaceut.4c00202 |