Challenges of Psychiatry Drug Development and the Role of Human Pharmacology Models in Early Development—A Drug Developer's Perspective
Bibliographic Data
| ID | 15522775 |
|---|---|
| Authors | Tong Zhu (0000-0001-5704-4264, Astellas Pharma (United States), corresponding author) |
| Year | 2021 |
| Volume | 11 |
| Pages | 562660-562660 |
| Publication date | 2021-01-27 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Frontiers in Psychiatry (JOURNAL) |
| Journal identifiers | ISSN: 1664-0640 • E-ISSN: 1664-0640 |
| Publisher | Frontiers Media (PUBLISHER • CH) |
| DOI | 10.3389/fpsyt.2020.562660 |
| PMID | 33584358 |
| OpenAlex | W3121225585 |
| Language | EN |
| Citations received | 1 |
| References cited | 21 |
Psychiatric diseases have the lowest probability of success in clinical drug development. This presents not only an issue to address the unmet medical needs of patients, but also a hurdle for pharmaceutical and biotech industry to continue R&D in this disease area. Fundamental pharmacokinetic and pharmacodynamic principles provide an understanding of the drug exposure, target binding and pharmacological activity at the target site of action for a new drug candidate. Collectively, these principles determine the likelihood of testing the mechanism of action and enhancing the likelihood of candidate survival in Phase 2 clinical development, therefore, they are termed as the "three pillars of survival." Human Phase 1 pharmacokinetic and pharmacodynamic studies provide evidence of the three pillars. Electroencephalogram (EEG) assessments and cognitive function tests in schizophrenia patients can provide proof of pharmacology and ensure that a pharmacological active regimen will be tested in Phase 2 proof of concept (POC) studies for the treatment of cognitive impairment associated with schizophrenia (CIAS)
Clinical pharmacology · Drug · Drug action · Drug development · Pharmacodynamics · Pharmacokinetics · Psychiatry · Schizophrenia (object-oriented programming · Attention Deficit Hyperactivity Disorder · Bipolar Disorder and Treatment · Medicine · Schizophrenia research and treatment · Pharmacology
| Citations per year | 0.5 |
|---|---|
| Citation span | 2024 - 2024 (1) |
| Highly cited | No |