'Pk parameters' diaporamas de présentation

Bioequivalence General Considerations

Bioequivalence General Considerations. Dr. John Gordon. WHO Prequalification of Medicines Programme Assessment Training Copenhagen, January 18-21, 2012. Key Output of Programme.

1.21k views • 70 slides

Noncompartment Model - Pharmacokinetics

Grcp. CVS. Noncompartment Model - Pharmacokinetics. Dr C. V. S. Subrahmanyam. Principal. Gokaraju Rangaraju College of Pharmacy. Hyderabad. Grcp. CVS. Noncompartment Model - Pharmacokinetics. Objectives of this session. The participant shall be able to:.

1.63k views • 44 slides

PULSAR ASTRONOMY

PULSAR ASTRONOMY . Past, Present and Future. Andrew Lyne. SUMMARY. Introduction Pulsar Timing Pulsars as Tools Recent Advances The Future. Formation. Pulsars are created in Supernova-explosions:. Burning Phase. Collapse. Supernova Explosion. Angular momentum and magnetic

845 views • 41 slides

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT. Ramana S. Uppoor, R.Ph., Ph.D. Division of Clinical Pharmacology-1 Office of Clinical Pharmacology, CDER, FDA. ASENT meeting, March 6, 2008. Disclaimer. Views expressed are mine and do not necessarily reflect official FDA Policy.

700 views • 37 slides

Pharmacokinetic Models

1.44k views • 37 slides

PK/PD Modeling in Support of Drug Development

PK/PD Modeling in Support of Drug Development. Alan Hartford, Ph.D. Associate Director Scientific Staff Clinical Pharmacology Statistics Merck Research Laboratories, Inc. alan_hartford@merck.com. Outline. Introduction Purpose of PK/PD modeling The Model Modeling Procedure

671 views • 30 slides

Statistical Criteria for Establishing Bio-inequivalence among Drug Products

Statistical Criteria for Establishing Bio-inequivalence among Drug Products . Qian H. Li, Lawrence Yu, Donald Schuirmann, Stella Machado, Yi Tsong CDER, FDA. Outline of the Presentation . Definition of bio-inequivalence Explanation on failing to show bioequivalence

535 views • 26 slides

Speaker: Wun -Han Huang Date : 2012. 06. 19

Preclinical Pharmacokinetic and Pharmacodynamic Evaluation of Novel Anticancer Agents, ON01910.Na and ON013105, for Brain Tumor Chemotherapy. Speaker: Wun -Han Huang Date : 2012. 06. 19. Brain Tumor- G liomas.

447 views • 23 slides

The Ideal DMPK Profile versus Lead Optimization

Clinical DMPK Profile. Rationale. High oral bioavailability: Half-life between 12 and 24 hr: Multiple elimination pathways: No reactive metabolites: No human-specific metabolites: No inhibition of CYP450 enzymes: No induction of CYP enzymes:. Low inter-subject variability/ cost of goods

510 views • 19 slides

PHARMACOMETRICS

PHARMACOMETRICS. Systems Pharmacology Quantitative Pharmacology Pharmacokinetics on Steroids. Noncompartmental Analyses. WinNonlin Area-under-the-curves (AUCs) Cmax Tmax Half-life Bioavailability fraction. Compartmental Modeling. Assume model

456 views • 16 slides

Qualification of an exposure-categorical ordered multi-response population model of inolimomab in graft-versus-host dis

Liver. GUT. Skin. Patients. PK and PKPD analysis. PK and PD assessments. ACOP 2008. 45. Qualification of an exposure-categorical ordered multi-response population model of inolimomab in graft-versus-host disease.

182 views • 1 slides

A single-dose study to evaluate the pharmacokinetics, safety, and tolerability of

P1423. Boston , MA 02111 617.275.0040 x255 mdraper@paratekpharm.com. A single-dose study to evaluate the pharmacokinetics, safety, and tolerability of multiple formulations of PTK 0796 in healthy subjects

122 views • 1 slides

Background

74 views • 1 slides