bioRASI
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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

bioRASI is a Full Service Global CRO that collaborates with the leading biotech and pharmaceutical companies in the clinical development of novel and generic therapeutics.


Specializing in ANDA and 505(b)(2) NDA programs, bioRASI facilitates obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time.


bioRASI services include the full spectrum of program management, regulatory, clinical, data management and analysis, and compliance and audit. bioRASI leverages its access to well renowned researchers and facilities, in the U.S., Europe and Asia, to achieve unparalleled scientific, clinical and business results at significantly lower costs.


bioRASI is headquartered in Hollywood, FL and has regional offices, labs, and clinics across the globe.

Oct. 29, 2009 - bioRASI to Exhibit at the 2009 Annual AAPS Meeting in Los Angeles

The Leading ANDA and 505(b)(2) CRO to Showcase Techniques
on Reducing Variability of Clinical Endpoint Trials