________ Full Service Global CRO ________
A N D A a n d 5 0 5( b )( 2 ) N D A
P r o g r a m s f r o m A t o Z
D i f f i c u l t t o R e c r u i t ,
D i f f i c u l t t o P e r f o r m
I n n o v a t i v e T h e r a p e u t i c s
S t u d i e s
|
Clinical Trial News
October 2009
Analytical Testing Completed - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Database Lock - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Herpe Labialis
Last Subject Out - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Foot Xerosis
Analytical Testing Completed - Pilot, Bioequivalence, Healthy Volunteers
September 2009
Clinical Procedures Completed - Pilot, Bioequivalence, Healthy Volunteers
Final Report Submitted - Bioequivalence, ANDA Program, Epileptic Patients
Trial Regulatory Approval Obtained - Dermal Safety and Adhesion, ANDA Program, Transdermal Delivery System, Post Menopausal Women
Analytical Testing Completed - Pilot, Bioequivalence, Healthy Volunteers
Clinical Procedures Completed - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
August 2009
First Subject In - Bioequivalence, ANDA Program, Transdermal Delivery System, Hypogonadal Men Last Subject Out - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Herpe Labialis First Subject In - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Foot Xerosis July 2009
Final Report Submitted -Bioequivalence, ANDA program, Patients with Advanced Solid Tumors
Analytical Testing Completed - Bioequivalence, ANDA Program, Epileptic Patients
Clinical Trial Procedure Completed - Pilot, Bioequivalence, Healthy Volunteers
June 2009
Trial Regulatory Approval Obtained - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Foot Xerosis
Database Lock - Bioequivalence, ANDA program, Patients with Advanced Solid Tumors
Clinical Trial Procedure Completed - Bioequivalence, ANDA Program, Epileptic Patients
May 2009
Final Report Submitted - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Trial Regulatory Approval Obtained - Pilot, Bioequivalence, Healthy Volunteers
First Subject In - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Herpe Labialis
Trial Regulatory Approval - Bioequivalence, ANDA Program, Transdermal Delivery System, Hypogonadal Men
April 2009
Last Subject Out - Bioequivalence, ANDA program, Patients with Advanced Solid Tumors
Trial Regulatory Approval Obtained - Bioequivalence, ANDA Program, Epileptic Patients
Final Report Submitted - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Final Report Submitted - Clinical Equivalence, 505 (b)(2) NDA program, Transdermal Delivery System, Hypogonadal Men
March 2009
Trial Regulatory Approval - Clinical Equivalence, ANDA Program, Transdermal Delivery System, Subjects with Herpe Labialis
Final Report Submitted - Pilot, Bioequivalence, Healthy Volunteers
Last Subject Out- Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Trial Regulatory Approval Obtained - Pilot, Bioequivalence, Healthy Volunteers
February 2009
Analytical Testing Completed - Pilot, Bioequivalence, Healthy Volunteers
Final Report Submitted - Bioequivalence, ANDA Program, Patients with Malignant Solid Tumors
Final Report Submitted - Pharmacokinetics, Patients with Confirmed HIV-1 Infection
First Subject In - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Database Lock - Clinical Equivalence, 505 (b)(2) NDA program, Transdermal Delivery System, Hypogonadal Men
January 2009
First Subject In - Bioequivalence, ANDA program, Patients with Advanced Solid Tumors
Analytical Testing Completed - Bioequivalence, ANDA Program, Patients with Malignant Solid Tumors
Analytical Testing Completed - Pharmacokinetics, Patients with Confirmed HIV-1 Infection
Final Report Submitted - Efficacy, Safety and Pharmacokinetic Study, 505(b)(2) Program, Mild-to-Moderate Asthma Patients
December 2008
Clinical Procedures Completed - Pharmacokinetics, Patients with Confirmed HIV-1 Infection
Clinical Procedures Completed - Pilot, Bioequivalence, Healthy Volunteers
Last Subject Out - Clinical Equivalence, 505 (b)(2) NDA program, Transdermal Delivery System, Hypogonadal Men
Analytical Testing Completed - Efficacy, Safety and Pharmacokinetic Study, 505(b)(2) Program, Mild-to-Moderate Asthma Patients
November 2008
Final Report Submitted - Phase I, NDA, Cancer Vaccine Program
Trial Regulatory Approval Obtained - Steady State, Pharmacokinetic, ANDA Program, Schizophrenic Patients
Final Report Submitted - Bioequivalence, ANDA Program, Healthy Volunteers
Clinical Procedures Completed - Bioequivalence, ANDA Program, Patients with Malignant Solid Tumors
Trial Regulatory Approval Obtained - Bioequivalence, ANDA program, Patients with Advanced Solid Tumors
|
|