Data No
|
Data Source*
|
Author(s)
|
Title
|
Date
|
Data Type
|
Data Sub-type
|
Authorising
Party
|
Inherited
Application
No.
|
35189
|
S
|
G Michels, LM D‚jardin, CE DeCamp.
|
Evaluation of the Efficacy of a Novel Nonsteroidal Anti-Inflammatory Drug (NSAID) for the Treatment of Osteoarthrosis in vivo - A Kinetic Analysis in a Canine Cranial Cruciate Ligament Deficient Stifle Model.
|
July 2004
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35193
|
S
|
M Payne-Johnson, M Stegemann, N Tilt, A Fleetwood.
|
Determination of the efficacy and safety of PHA 739521 [Mavacoxib] oral tablets administered monthly at 2 mg/kg, following a loading dose interval of approximately 14 days, in the treatment of pain and inflammation associated with osteoarthritis in dogs.
|
27 September 2006
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35192
|
S
|
M Payne-Johnson, M Stegemann, J Sherington, A Fleetwood.
|
Measurement of residual mavacoxib plasma concentrations in mavacoxib-treated dogs enrolled in Study 5962C-85-04-289.
|
13 November 2006
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35191
|
S
|
M Payne-Johnson, M Stegemann, J Sherington, A Fleetwood.
|
Determination of the efficacy and safety of mavacoxib oral tablets administered two times at 4 mg/kg, with the second dose following a loading dose interval of approximately 14 days, in the treatment of pain and inflammation associated with osteoarthritis in dogs.
|
2 February 2006
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35190
|
S
|
M Payne-Johnson, M Stegemann, J Sherington, A Fleetwood.
|
Determination of the efficacy and safety of mavacoxib oral tablets administered monthly at 4 mg/kg, following a loading dose interval of approximately 14 days, in the treatment of pain and inflammation associated with osteoarthritis in dogs.
|
1 November 2006
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35188
|
S
|
GM Michels, GV Tucker.
|
Dose response of PHA-739521 [Mavacoxib] oral tablets compared to a negative control in an induced-lameness canine acute synovitis model 30 days following completion of a loading dose interval.
|
2 July 2004
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35187
|
S
|
B Hummel, PM Guimond, M Darling.
|
Evaluation of SC-58500 [Mavacoxib] at 4 mg/kg PO in a canine inflammation model.
|
10 April 2002
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35194
|
S
|
M Payne-Johnson, M Stegemann, JF Boucher, A Fleetwood.
|
Measurement of residual mavacoxib plasma concentrations in mavacoxib-treated dogs enrolled in Study 5962C-85-05-307.
|
11 June 2007
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35186
|
S
|
B Hummel, SG Kamerling, PM Guimond, M Darling.
|
Evaluation of SC-58500 [Mavacoxib] at 2 mg/kg PO in a canine inflammation model: Comparison of efficacy and plasma concentrations.
|
18 January 2003
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35185
|
S
|
SH St Denis, MA Hickman.
|
Analgesic Efficacy of PHA-739521 [Mavacoxib] in the canine synovitis model.
|
11 July 2003
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35184
|
S
|
TM Kubiak, SJ Alexander-Bowman, S Mahabir.
|
Determination of COX1 and COX2 inhibition (IC50s and ratios) for Carprofen and Mavacoxib in the canine in vitro whole blood assay.
|
4 December 2006
|
Efficacy and Safety
|
Efficacy
|
Applicant
|
|
35183
|
S
|
Toutain, P. L., Cester, C. C., Haak, T. & Laroute, V.
|
A pharmacokinetic/pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog.
|
2001
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35182
|
S
|
Toutain, P. L.
|
Population PK and PK/PD investigations and Monte-Carlo simulations for a rational dosage regimen.
|
2006
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35181
|
S
|
Paulson SK, Zhang JY, Jessen SM, Lawal Y, Liu NW, Dudkowski Cm, Wang YF, Chang M, Yang D, Findlay JW, Berge MA, Markos CS, Breau AP, Hribar JD, Yuan J
|
Comparison of celecoxib metabolism and excretion in mouse, rabbit, dog, cynomolgus monkey and rhesus monkey.
|
2000
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35180
|
S
|
Newcombe, R.G.
|
Interval estimation for the difference between independent proportions: comparison of eleven methods.
|
1998
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35175
|
S
|
Lees, P.
|
Pharmacology of drugs used to treat osteoarthritis in veterinary practice.
|
2003
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35173
|
S
|
Cross AR, Budsberg SC, & Keefe TJ
|
Kinetic gait analysis assessment of meloxicam efficacy in a sodium urate-induced synovitis model in dogs.
|
1997
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35209
|
S
|
J Elliott
|
Addendum to Expert Report Clinical Documentation on Mavacoxib
|
January 2008
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35172
|
S
|
Borer LR, Peel JE, Seewald W, Schawalder P and Spreng DE
|
Effect of carprofen, etodolac, meloxicam or butorphanol in dogs with induced acute synovitis.
|
2003
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35206
|
S
|
J Elliott
|
Expert Report Clinical Documentation on Mavacoxib
|
March 2007
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35210
|
S
|
SP Lesman, BD Hummel.
|
Validation of an LC-MS/MS Assay for the Determination of PHA-739521 in Dog Plasma.
|
17 October 2006
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35211
|
S
|
S Lesman, Tian-Sheng Lu, RD Jones, AJ Wirscham.
|
Ricera Project 018418: Method Validation of an LC-MS/MS Assay for the Determination of PHA-739521 in Canine Plasma.
|
30 September 2005
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35177
|
S
|
Luna SPL, Basilio AC, Steagall PVM, Machado LP, Moutinho FQ, Takahira RK, and Brandao VS
|
Evaluation of adverse effects of long-term oral administration of carprofen, etodolac, flunixin meglumine, ketoprofen and meloxicam in dogs.
|
2007
|
Efficacy and Safety
|
Other Information
|
Public
|
|
35208
|
S
|
P Lees
|
Expert Report on the Dosage of Mavacoxib Selected for Clinical Use in the Dog
|
25 February 2008
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35205
|
S
|
P Lees
|
Expert Report on the Efficacy of Mavacoxib: A selective COX-2 inhibitor for use in canine osteoarthritis
|
21 March 2007
|
Efficacy and Safety
|
Other Information
|
Applicant
|
|
35171
|
S
|
SR Cox, RJ Zielinski.
|
Assay for the Concentration of PHA-739521 in Plasma Samples for the European Canine FSE Study 5962C-85-04-289.
|
1 November 2006
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35198
|
S
|
SR Cox.
|
Development of a Population Pharmacokinetic Model for PHA 739521 [Mavacoxib] in Dogs Based on Data from Laboratory Animal Studies.
|
7 November 2006
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35199
|
S
|
S Liao, SR Cox.
|
Population Pharmacokinetic Analysis of Plasma PHA 739521 [Mavacoxib] Concentration Data from Study 5962C 85 04 289.
|
29 October 2006
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35200
|
S
|
S Liao, SR Cox.
|
Population Pharmacokinetic Analysis of Plasma PHA 739521 [Mavacoxib] Concentration Data from Study 5962C-85-06-316.
|
18 November 2006
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35201
|
S
|
S Liao, SR Cox.
|
Monte Carlo Simulation of PHA-739521 Trough Plasma Concentrations in Support of PHA-739521 Dosage Recommendation in the Treatment of Pain and Inflammation Associated with Osteoarthritis in Dogs.
|
30 November 2006
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35202
|
S
|
S Liao, SR Cox, JA Robinson.
|
Population Pharmacokinetic Analysis of Plasma PHA-739,521 Concentration Data from Studies 5962C-85-05-307 and 5962C-12-07-349.
|
11 September 2007
|
Efficacy and Safety
|
Pharmacological Data/Studies
|
Applicant
|
|
35203
|
S
|
C Locuson, SR Cox.
|
Canine Drug-Drug Interaction Assessment for PHA-739521.
|
9 January 2008
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35165
|
S
|
W Seaman.
|
7-Week Oral Safety Study of Carprofen (Rimadyl©) Therapy Following Exposure to PHA-739521 in Female Dogs.
|
14 October 2005
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35197
|
S
|
MC Savides.
|
Oral Safety Study of Carprofen (Rimadyl©) Therapy Following Exposure to Mavacoxib in Mongrel Dogs.
|
12 October 2006
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35196
|
S
|
MC Savides.
|
Gastric Endoscopy and Buccal Mucosal Bleeding Time Study with Mavacoxib (Orally Administered by Tablets) in Mongrel Dogs.
|
10 November 2006
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35195
|
S
|
MC Savides.
|
Gastrointestinal Irritation Study With Mavacoxib (Orally Administered by Tablets) in Mongrel Dogs.
|
12 October 2006
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35166
|
S
|
W Seaman.
|
PHA-739521 and Carprofen (Rimadyl©): A 7-Week Oral Safety Study of Carprofen Therapy Following Exposure to PHA-739521 in the Dog.
|
16 May 2005
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35145
|
S
|
MC Savides.
|
Margin-of-Safety of Mavacoxib Administered Orally in Dogs.
|
26 January 2007
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
35164
|
S
|
W Seaman, D Blunt.
|
Acute Oral (Tablets) Tolerance Study of PHA-739521 in Beagle and Mongrel Dogs.
|
24 August 2005
|
Efficacy and Safety
|
Target Animal Safety Studies
|
Applicant
|
|
