Pharmacokinetic

Perforomist-comparable pharmacokinetic and pharmacodynamic profile to DPI formulation

Napa, CA (May 20, 2008) Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist™ Inhalation Solution (formoterol fumarate inhalation solution; FFIS) has a pharmacodynamic and pharmacokinetic profile that is comparable to the d...

Phase I pharmacokinetic study of ECO-4601, a novel bifunctional targeting agent

SAN FRANCISCO -- Researchers report positive results from a Phase I/II clinical trial of a novel anti-cancer drug which offers two modes of action. In 26 patients with advanced solid tumors, treatment with ECO-4601 is safe and well tolerated, including at doses yielding plasma concentrations abov...

Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations

...itable companion diagnostic test kit globally available. Data for BIBF 1120 in NSCLC Also presented at the conference were results from a pharmacokinetic analysis of another Boehringer Ingelheim compound, BIBF 1120, an angiogenesis inhibitor that simultaneously inhibits vascular endothelial growth facto...

FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

...ics has agreed to Post-Marketing Commitments (PMC) to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. "We are well underway with the modifications to the TYVASO Inhalation System," said Roger Je...

AcelRx Announces Perfect Performance of Handheld Component of ARX-01 Sufentanil NanoTab PCA System in a Phase 2 Study

...been limited due to its short IV plasma half-time. In the NanoTab oral transmucosal dosage form, sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for post-operative PCA usage and has the potential for improved patient tolerability over IV PCA morphine. About AcelRx Pharmaceutic...

Labopharm receives complete response letter from the U.S. FDA for novel antidepressant

...FDA when available. Labopharm submitted the NDA for its novel formulation of trazodone in September 2008. The NDA is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo-controlled clinical trial (study 04ACL3-001), which enrolled more than 400 ...

New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies

...cific Populations Hepatic impairment: PREZISTA/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment. Pregnancy: PREZISTA should be used during pregnancy only if the potential...

Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance(TM) for Treatment of Acute Pain and Fever

...A is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric pati...

Peregrine Pharmaceuticals Reports Financial Results for Fiscal Year 2009

...atients with advanced refractory cancers. At the 2009 ASCO Annual Meeting, study researchers reported that bavituximab had demonstrated a predictable pharmacokinetic profile and acceptable safety, and that a maximum tolerated dose was not reached, even at the highest planned dose level. Announced that the A...

Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)

... with major bleeding events. In addition, the results from a pharmacogenetic substudy of TRITON-TIMI 38 patients, as well as several early phase pharmacokinetic studies, showed that the active form of prasugrel does not appear to be affected by genetic variations in common cytochrome P450 (CYP) enzymes, inclu...

Pharmacokinetic in Medical Technology

New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

PHILADELPHIA, May 22 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY ), the global specialty biopharmaceutical company, announced results of a study showing that coadministration of the ADHD medication VYVANSE(R) (lisdexamfetamine dimesylate) CII with the proton pump inhibitor (PP...

Sequoia Pharmaceuticals Presents Proof of Clinical Concept of SPI-452, a Novel Pharmacokinetic Enhancer

MONTREAL, Feb. 9 /PRNewswire/ -- Sequoia Pharmaceuticals presented positive results today from two phase 1 studies in healthy volunteers and preclinical studies on SPI-452, a novel pharmacokinetic enhancer (PKE) with no inherent antiviral activity. Pharmacokinetic enhancers increase drug level...

MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate

Lower systemic drug exposure observed compared to currently marketed conventional nebulized budesonide MOUNTAIN VIEW, Calif., March 24 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today that in a pharmacokinetic clinical trial Unit Dose Bud...

PTC Therapeutics Announces Pharmacokinetic and Safety Results from Phase 2 Study of PTC124 in Duchenne Muscular Dystrophy

- Data Presented at 36th Child Neurology Society Annual Meeting - SOUTH PLAINFIELD, N.J., Oct. 11 /PRNewswire/ -- PTC Therapeutics, Inc. (PTC), a biopharmaceutical company focused on the discovery, development and commercialization of small-molecule drugs targeting post-transcriptional cont...

Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference

SAN CARLOS, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR ) announced today that preclinical data for its proprietary product candidate NKTR-102 (PEG-irinotecan) will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Th...

Alpharma Presents Positive Pharmacokinetic Study Results of Its Investigational Abuse-Deterrent, Extended-Release Opioid

BRIDGEWATER, N.J., May 03, 2007 /PRNewswire-FirstCall/ -- Alpharma Inc. , a leading global specialty pharmaceutical company through its Pharmaceuticals Division, this week presented positive results of a pharmacokinetic study of its investigational abuse-deterrent, extended-release opioid at the 2...

Modigene Announces Successful Completion of Pharmacokinetic & Pharmacodynamic Pre-Clinical Experiments for Proprietary Long-Acting Human Growth Hormone, Long-acting Interferon Beta and Long-acting Erythropoietin

VIENNA, Va., June 20, 2007 /PRNewswire/ -- Modigene Inc., a Nevada corporation today announced the successful completion of pharmacokinetic and pharmacodynamic pre-clinical experiments for long-acting human growth hormone, long-acting interferon beta and long-acting erythropoietin. Modigene's ph...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...n discussions with potential partners to support the commercialization of our product in Canada." Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 pa...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...0.49 log(10) IU/mL, -0.61 log(10) IU/mL and -1.01 log(10) IU/mL in patients receiving 50mg QD, 100mg QD, and 200mg QD, respectively. PSI-7851 pharmacokinetic and Safety Summary Pharmacokinetics were similar between healthy subjects in the single ascending dose study and HCV infected patients in the mult...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

...tential treatment for the prevention of both arterial and venous thromboembolism; a Phase III trial is underway among patients with AF. This pharmacokinetic (PK) analysis of the Phase IIb study examined the relationship between bleeding events reported in patients taking 30 or 60 mg edoxaban given either Q...

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Pharmacokinetic in Biological News

Gene mutation increases drug toxicity, rejection risk in pediatric kidney transplants

...ks' division at Cincinnati Children's. The research team recently completed pharmacokinetic and biomarker studies which analyze how the body metabolizes a drug to so...ric kidney transplant patients. Researchers want to use data from these pharmacokinetic studies as a basis for showing whether increased MMF exposure in adults can...

Scripps Florida scientists awarded $1.5M to fight major water and food parasites

...dy been developed against this enzyme family. As a result, a wealth of inhibitor leads already exist, many of which have been subject to extensive pharmacokinetic and safety studies; for example cysteine protease inhibitors have already demonstrated potent anti-trypanosomal effects. "This family of enzymes is...

Experts from Stevens, Merck, publish joint paper, 'Biosynthetic Studies of Platensimycin'

...istered by continuous infusion; however, the efficacy is reduced when administered by conventional routes. This phenomenon is attributed to their poor pharmacokinetic properties which could potentially be improved by chemical modification of the natural product, via total synthesis and through combinatorial biosynth...

PET/MRI scans may help unravel mechanisms of prenatal drug damage

...the fetal brain. "The MRI images, which have the necessary detail, served as a high-resolution anatomical template onto which we 'overlaid' the PET pharmacokinetic data using sophisticated computer techniques," Benveniste said. "The resulting images gave us the best of both worlds and allowed us to look at cocain...

Pharmacokinetic in Biological Technology

Tobira Therapeutics Inc. Announces Phase I Data Demonstrating Pharmacokinetic Properties of TAK-652 for the Treatment of HIV

PRINCETON, N.J. and SAN DIEGO, July 22 /PRNewswire/ -- Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and result...

Helix BioPharma Receives Approval to Initiate Phase II Pharmacokinetic Clinical Study of Topical Interferon Alpha-2b in Patients with Low-Grade Cervical Lesions

AURORA, Ontario, March 16 /PRNewswire/ -- Helix BioPharma Corp. (TSX, FSE: "HBP") announced that it has received the necessary regulatory approvals in Germany to initiate its planned Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions. The...

ImQuest Presents IND-Enabling Safety Pharmacology and Pharmacokinetic Data for the Therapeutic HIV Compound IQP-0410 at Conference on Retroviruses and Opportunistic Infections

FREDERICK, Md., Feb. 9 /PRNewswire/ -- ImQuest Life Sciences today presented important new results on the continued development of their small molecule inhibitor of HIV-1 at the 16th CROI meeting held this week in Montreal. The presentation highlighted the advanced development of ImQuest's lead HI...

Human clinical study demonstrates superior Neptune Krill Oil NKO(R) pharmacokinetic profile

- Marine omega-3 phospholipids in NKO(R) outperform established nutraceutical and pharmaceutical omega-3 formulations - - Study results used to direct Acasti Pharma's prescription drug program - LAVAL, QC, Nov. 19 /PRNewswire-F...

Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation

- Data from two clinical trials presented at International ATS Conference - NAPA, Calif., May 20 /PRNewswire/ -- Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist(TM) Inhalation Solution (formoterol fumarate inhalation soluti...

Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences

MUNICH, Germany, March 10 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO ), a biopharmaceutical company developing and commercializing products based on the extracellular matrix, today announced new safety and pharmacokinetic data from a second generation manufacturing pr...

PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008

ANNAPOLIS, Md., March 6 /PRNewswire-FirstCall/ -- PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that it has completed the initial pharmacokinetic (PK) testing of ...

ADVENTRX to Present Complete ANX-530 Pharmacokinetic Data at the 2008 American Association for Cancer Research Annual Meeting

SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ), announced today that complete pharmacokinetic data from the Company's marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has been accepted for presentation at the 2008 Amer...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

...alfa-2a) and Copegus(R) (ribavirin) in HCV-infected patients. Ritonavir is an antiviral compound commonly used at low doses to enhance or "boost" the pharmacokinetic (PK) profiles of several marketed HIV protease inhibitors and at least one other HCV protease inhibitor in development. In an initial Phase 1 study o...

Palatin Technologies, Inc. Receives U.S. Patent Allowance for Heart Failure Drug Candidate

... are first-in-class peptide mimetics with extended half-lives and favorable pharmacokinetic properties. These are the only drugs we are aware of that bind to NPRA and...degrades natriuretic peptides. The result is a drug candidate with improved pharmacokinetic and pharmacodynamic properties. About Heart Failure Heart fai...

Pharmacokinetic in Biological Dictionary

Proteasome

...some Inhibitors: The multicatalytic proteasome is the ubiquitous ... The pharmacokinetic and Pharmacodynamic Profiles of Proteasome Inhibitors ... Proteasome Inhibitors in Disease: The multicatalytic proteasome is the ... The pharmacokinetic and Pharmacodynamic Profiles of Proteasome Inhibitors ... ... Processi...