Getting Innovative Therapies Faster to Patients at the Right Dose : Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics..
Quantitative pharmacology (QP) applications in translational medicine, drug-development, and therapeutic use were crowd-sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial-burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model-informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy.
| Errataetall: |
ErratumIn: Clin Pharmacol Ther. 2018 Nov;104(5):1031. - PMID 30347455 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2018 |
|---|---|
| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:103 |
|---|---|
| Enthalten in: |
Clinical pharmacology and therapeutics - 103(2018), 3 vom: 01. März, Seite 378-383 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Nayak, Satyaprakash [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 12.04.2019 Date Revised 04.12.2021 published: Print-Electronic ErratumIn: Clin Pharmacol Ther. 2018 Nov;104(5):1031. - PMID 30347455 Citation Status MEDLINE |
|---|
| doi: |
10.1002/cpt.978 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM279931484 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM279931484 | ||
| 003 | DE-627 | ||
| 005 | 20231225024157.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2018 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/cpt.978 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0933.xml |
| 035 | |a (DE-627)NLM279931484 | ||
| 035 | |a (NLM)29330855 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Nayak, Satyaprakash |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Getting Innovative Therapies Faster to Patients at the Right Dose |b Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.04.2019 | ||
| 500 | |a Date Revised 04.12.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ErratumIn: Clin Pharmacol Ther. 2018 Nov;104(5):1031. - PMID 30347455 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. | ||
| 520 | |a Quantitative pharmacology (QP) applications in translational medicine, drug-development, and therapeutic use were crowd-sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial-burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model-informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Pharmaceutical Preparations |2 NLM | |
| 700 | 1 | |a Sander, Oliver |e verfasserin |4 aut | |
| 700 | 1 | |a Al-Huniti, Nidal |e verfasserin |4 aut | |
| 700 | 1 | |a de Alwis, Dinesh |e verfasserin |4 aut | |
| 700 | 1 | |a Chain, Anne |e verfasserin |4 aut | |
| 700 | 1 | |a Chenel, Marylore |e verfasserin |4 aut | |
| 700 | 1 | |a Sunkaraneni, Soujanya |e verfasserin |4 aut | |
| 700 | 1 | |a Agrawal, Shruti |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Neeraj |e verfasserin |4 aut | |
| 700 | 1 | |a Visser, Sandra A G |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical pharmacology and therapeutics |d 1960 |g 103(2018), 3 vom: 01. März, Seite 378-383 |w (DE-627)NLM000015318 |x 1532-6535 |7 nnns |
| 773 | 1 | 8 | |g volume:103 |g year:2018 |g number:3 |g day:01 |g month:03 |g pages:378-383 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/cpt.978 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 103 |j 2018 |e 3 |b 01 |c 03 |h 378-383 | ||