bioRASI
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Clinical Trial News







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
Database Lock - 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
October 2008
Final Report Submitted - 505(b)(2), Transdermal Delivery System, Post-Menopausal Women
Trial Regulatory Approval Obtained - Clinical Equivalence, ANDA Program, Topical Application, Acne Vulgaris
Analytical Testing Completed - Bioequivalence, ANDA Program, Healthy Volunteers
Final Report Submitted - Bioequivalence, ANDA Program, Orphan Drug
Trial Regulatory Approval ObtainedPilot, Bioequivalence, Healthy Volunteers
September 2008
Clinical Procedures Completed - Bioequivalence, ANDA Program, Healthy Volunteers
Analytical Testing Completed - Bioequivalence, ANDA Program, Orphan Drug
Database Lock - 505(b)(2), Transdermal Delivery System, Post-Menopausal Women
Database Lock - Phase I, NDA, Cancer Vaccine Program
Trial Regulatory Approval Obtained - Pharmacokinetics, Patients with Confirmed HIV-1 Infection
Clinical Procedures Completed - Efficacy, Safety and Pharmacokinetic Study, 505(b)(2) Program, Mild-to-Moderate Asthma Patients
August 2008
Clinical Procedures Complete - Bioequivalence, ANDA Program, Orphan Drug
Trial Regulatory Approval Obtained - Bioequivalence, ANDA Program, Healthy Volunteers
First Subject In - Clinical Equivalence, 505 (b)(2) NDA program, Transdermal Delivery System, Hypogonadal Men
Trial Regulatory Approval Obtained - Bioequivalence, ANDA Program, Patients with Malignant Solid Tumor
July 2008
Final Report Submitted - Safety & Efficacy, NDA, Antimuscarinic Agonist
Trial Regulatory Approval Obtained - Bioequivalence, ANDA Program, Orphan Drug
Final Report Submitted - Human Dermal Safety & Adhesion, ANDA Program, Transdermal Delivery System, Post Menopausal Women
Last Subject Out - Phase I, NDA, Cancer Vaccine Program
June 2008
Trial Regulatory Approval Obtained - Clinical Equivalence, 505 (b)(2) NDA program, Transdermal Delivery System, Hypogonadal Men
Database Lock - Safety & Efficacy, NDA, Antimuscarinic Agonist
Trial Regulatory Approval Obtained - Efficacy, Safety and Pharmacokinetic Study, 505(b)(2) program, Mild-to-Moderate Asthma Patients

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.

May 27, 2009 - bioRASI to Present at the MAGI 2009 Clinical Research Conference in Miami, FL

A Leading Global CRO to Present its Continuous Improvement Model