Literature DB >> 10557596

Guidance for industry on Population Pharmacokinetics; availability. Food and Drug Administration, HHS. Notice.

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Abstract

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Population Pharmacokinetics." This guidance provides recommendations to pharmaceutical industry scientists, who have long been interested in the application of population pharmacokinetics, during the new drug development, safety and efficacy evaluation, and approval processes.

Mesh：

Year:  1999        PMID： 10557596

Source DB:  PubMed          Journal:  Fed Regist        ISSN： 0097-6326


  14 in total

1.  Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method.

Authors:  Andrew C Hooker; Christine E Staatz; Mats O Karlsson
Journal:  Pharm Res       Date:  2007-07-06       Impact factor: 4.200

2.  Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections.

Authors:  C M Rubino; B Xue; S M Bhavnani; W T Prince; Z Ivezic-Schoenfeld; W W Wicha; P G Ambrose
Journal:  Antimicrob Agents Chemother       Date:  2014-10-27       Impact factor: 5.191

3.  Therapeutic drug monitoring of imatinib: Bayesian and alternative methods to predict trough levels.

Authors:  Verena Gotta; Nicolas Widmer; Michael Montemurro; Serge Leyvraz; Amina Haouala; Laurent A Decosterd; Chantal Csajka; Thierry Buclin
Journal:  Clin Pharmacokinet       Date:  2012-03-01       Impact factor: 6.447

4.  Population Pharmacokinetic Modeling of Canagliflozin in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus.

Authors:  Eef Hoeben; Willem De Winter; Martine Neyens; Damayanthi Devineni; An Vermeulen; Adrian Dunne
Journal:  Clin Pharmacokinet       Date:  2016-02       Impact factor: 6.447

5.  Population pharmacokinetic analysis for a single 1,200-milligram dose of oritavancin using data from two pivotal phase 3 clinical trials.

Authors:  C M Rubino; S M Bhavnani; G Moeck; S E Bellibas; P G Ambrose
Journal:  Antimicrob Agents Chemother       Date:  2015-03-30       Impact factor: 5.191

6.  Integrative population pharmacokinetic and pharmacodynamic dose finding approach of the new camptothecin compound namitecan (ST1968).

Authors:  M Joerger; D Hess; A Delmonte; E Gallerani; A Fasolo; L Gianni; S Cresta; P Barbieri; S Pace; C Sessa
Journal:  Br J Clin Pharmacol       Date:  2015-06-03       Impact factor: 4.335

7.  Unexpectedly high affinity of a novel histamine H(3) receptor antagonist, GSK239512, in vivo in human brain, determined using PET.

Authors:  S Ashworth; A Berges; E A Rabiner; A A Wilson; R A Comley; R Y K Lai; R Boardley; G Searle; R N Gunn; M Laruelle; V J Cunningham
Journal:  Br J Pharmacol       Date:  2014-03       Impact factor: 8.739

8.  HPLC method validation for the quantification of lomustine to study pharmacokinetics of thermosensitive liposome-encapsulated lomustine containing iohexol for CT imaging in C6 glioma rats.

Authors:  Luning Zhuang; Jing Gao; Yong Zeng; Fei Yu; Bingjie Zhang; Mu Li; Hartmut Derendorf; Changxiao Liu
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2011-03-05       Impact factor: 2.441

9.  Using Population Pharmacokinetic Modeling to Estimate Exposure to Δ9-Tetrahydrocannabinol in an Observational Study of Cannabis Smokers in Colorado.

Authors:  Cristina Sempio; L Cinnamon Bidwell; Kent Hutchison; Marilyn A Huestis; Jost Klawitter; Uwe Christians; Thomas K Henthorn
Journal:  Ther Drug Monit       Date:  2021-08-01       Impact factor: 3.118

10.  A Joint Model for the Kinetics of CTC Count and PSA Concentration During Treatment in Metastatic Castration-Resistant Prostate Cancer.

Authors:  M Wilbaux; M Tod; J De Bono; D Lorente; J Mateo; G Freyer; B You; E Hénin
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2015-04-24
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