Clirinx EDC Demo

Quick overview of Clirinx EDC

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation of EDC systems, please contact us

 

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Castor EDC Demo

Castor EDC Training and Support

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

Lung cancer is the leading cause of cancer-related death among men and women in the U.S. and, though more common in men, the number of deaths from lung cancer in women is increasing. According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. NSCLC is the most common type of lung cancer. Mutations in the EGFR gene are present in about 10 percent of NSCLC tumors.

Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa.

The FDA granted Iressa orphan product designation for the treatment of EGFR mutation-positive metastatic NSCLC. Orphan product designation is given to drugs intended to treat rare diseases, which provides financial incentives – like tax credits, user fee waivers, and eligibility for market exclusivity – to promote their development.

The efficacy and safety of Iressa for this use was demonstrated in a multi-center, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the tumors after treatment. Participants received Iressa 250 mg once daily. Results showed that tumors shrank in about 50 percent of patients after treatment and this effect lasted an average of six months. The response rates were similar in patients whether their tumors had EGFR exon 19 deletions or exon 21 L858R substitution mutations.

For more information, please visit: Iressa

Device Approvals: Edwards SAPIEN 3 Transcatheter Heart Valve

Device Approvals: Edwards SAPIEN 3 Transcatheter Heart Valve

The FDA has recently approved the Edwards SAPIEN 3 Transcatheter Heart Valve to be marketed.  The Edwards SAPIEN 3 Transcatheter Heart Valve (often referred to as SAPIEN 3 THV) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The SAPIEN 3 THV is the third generation of the SAPIEN THV that FDA originally approved in 2011. The device has a major design change that adds a skirt at the base of the valve frame to minimize leakage around the valve.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Device Approvals: activL® Artificial Disc

The FDA recently approved the activL® Artificial Disc to be marketed.  The activL® Artificial Disc is an implant that replaces the function of a damaged or diseased spinal disc. The activL® consists of two metal (cobalt-chromium with a titanium coating) endplates surrounding a plastic (polyethylene) insert. The endplates attach to the patient’s vertebrae, and the plastic insert fits between them. The insert is designed to move during daily activities.

For more information check FDA.com

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Clinical Pharmacology Corner Update: FDA Approves REXULTI (Brexpiprazole)

FDA Approves REXULTI® (Brexpiprazole) for the Treatment of Schizophrenia and Adjunctive Treatment of Major Depressive Disorder  

On July 10, 2015, the FDA approved REXULTI (brexpiprazole) immediate-release tablets for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder (MDD).

Dosage and Administration

  • Treatment of Schizophrenia: The recommended starting dose for REXULTI in the treatment of patients with schizophrenia is 1 mg once daily (QD). The dose should be increased to 2 mg after Day 4 and may subsequently be increased to 4 mg after Day 7 based on the patient’s clinical response and tolerability. The maximum recommended dose is 4 mg QD.
  • Adjunctive Treatment of MDD: The recommended starting dose for REXULTI as adjunctive treatment for MDD is 0.5 mg/day or 1 mg QD. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. The maximum recommended dose is 3 mg QD.
  • REXULTI can be administered with or without food.

General Pharmacokinetics and Pharmacodynamics of Brexpiprazole

The mechanism of action of brexpiprazole is unknown.  However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

  • Dose Proportionality: Brexpiprazole Cmax and AUC are approximately dose proportional after oral administration in the therapeutic dosage range.
  • Accumulation: About 4-fold at steady state (time to steady state 10 to 12 days)
  • Absolute bioavailability (tablets): 95% (Tmax within 4 hours).
  • Plasma protein binding: Greater than 99%.
  • Terminal half-life (mean): 91 hours at steady state.
  • Metabolism: Extensive. Predominately by CYP3A and CYP2D6.
  • Excretion: About 14% and less than 1% of the dose is excreted as unchanged parent drug in the feces and urine, respectively.
  • Exposure-safety: At a dose 3 times the maximum recommended dose, REXULTI does not prolong the QT interval to any clinically relevant extent.

Drug Interaction Potential

  • An approximately 2-fold increase in brexpiprazole exposure (AUC) was observed following coadministration of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole) with REXULTI. Decrease the REXULTI dosage by half if coadministration is required.
  • An approximately 2-fold increase in brexpiprazole exposure was observed following coadministration of a strong CYP2D6 inhibitor (e.g., quinidine, fluoxetine, paroxetine) with REXULTI. Decrease the REXULTI dosage by half if coadministration is required for the treatment of schizophrenia. A REXULTI dosage reduction is not required with coadministration in patients with MDD because this effect was factored into the general dosing recommendations (i.e., coadministration was permitted without dosage adjustment in the clinical trials supporting this indication).
  • An approximately 5.1-fold increase in steady-state brexpiprazole exposure is expected when extensive CYP2D6 metabolizers are coadministered REXULTI with both strong CYP2D6 and CYP3A4 inhibitors. Similarly, an approximately 4.8-fold increase in steady-state brexpiprazole exposure is expected when poor CYP2D6 metabolizers are coadministered REXULTI with strong CYP3A4 inhibitors. Decrease the REXULTI dosage by 75% if coadministration is required in patients with these polymorphisms.
  • An approximately 73% decrease in brexpiprazole exposure was observed following coadministration with a strong CYP3A4 inducer (e.g., rifampin, carbamazepine, phenytoin) with REXULTI. Double the REXULTI dosage one to two weeks following strong CYP3A4 inducer coadministration.

Use in Specific Populations

  • A 26%, 73%, and 4% increase in brexpiprazole exposure was observed in subjects with mild, moderate, and severe hepatic impairment compared to subjects with normal hepatic function, respectively. The maximum recommended REXULTI dosage for patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) is 2 mg QD for patients with MDD and 3 mg QD for patients with schizophrenia.
  • A 7%, 71%, and 72% increase in brexpiprazole exposure was observed or predicted in subjects or patients with mild, moderate, and severe renal impairment compared to subjects with normal renal function. The maximum recommended REXULTI dosage for patients with moderate or severe renal impairment (i.e., creatinine clearance less than 60 mL /minute) is 2 mg QD for patients with MDD and 3 mg QD for patients with schizophrenia.
  • Half of the usual dosage is recommended for patients with known CYP2D6 poor metabolizer status.

Safety and Efficacy

The efficacy and safety of REXULTI in schizophrenia was demonstrated in two 6-week controlled studies in adult patients at doses of 2 to 4 mg administered orally once daily. The primary efficacy endpoint in schizophrenia trials is change in PANSS Total Score from baseline to week 6. The efficacy and safety of REXULTI as an adjunctive therapy for MDD was evaluated in two 6-week controlled studies in adult patients at doses of 1 to 3 mg administered once daily, with one trial showing statistical superiority of REXULTI over placebo. The primary efficacy endpoint in MDD trials is the mean change in MADRS Total Score from baseline to week 6. Safety profiles were similar in MDD and schizophrenia patients. The most common treatment emergent adverse events were increased weight, headache, akathisia, somnolence, fatigue, anxiety, and increased appetite.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA approved Sonidegib

FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. July 24, 2015.

More Information:  http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455865.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Carfilzomib FDA Approved

FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple ymemloa who have received one to three prior lines of therapy. July 24, 2015.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455873.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

InForm EDC Features and Functionality

InForm 4.x Training
Learn the differences between 4.5 and 4.6 and new features

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.