Pharmacokinetics News and Research

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The term pharmacokinetics is derived from the ancient Greek words “pharmakon” and “kinetikos”, meaning “drug” and “putting in motion” respectively. It is one of the main branches of pharmacology, and refers to the way that the body reacts on and affects a pharmaceutical substance in the body.

HIV drug designed for children wins FDA approval

A pill containing 3 anti-HIV drugs designed specifically for children has been given tentative approval by the United States Food and Drug Administration (FDA). Its use in Sub-Saharan Africa will benefit thousands of children living with HIV.

10 Oct 2007

Biodel issued U.S. patent for VIAject and VIAtab

Biodel Inc. has announced the receipt of a notice of issuance from the United States Patent and Trademark Office (USPTO) for the Company's patent encompassing VIAject(TM) and VIAtab(TM), Biodel's two product candidates in clinical trials.

27 Sep 2007

MicroPET-based biodistribution of quantum dots in living mice

A wide variety of experiments have shown that nanoscale quantum dots have the potential to detect early-stage cancer and even monitor the progress of anticancer therapies.

27 Sep 2007

Ardea Biosciences completes phase 1 trials of HIV drug RDEA806

Ardea Biosciences, Inc. has announced that it has successfully completed Phase 1 single-ascending-dose, multiple-ascending-dose, food-effect, and drug-interaction studies of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), in healthy volunteers.

5 Sep 2007

Start of Phase II trial of intravenous artesunate for children with severe malaria

A multicentre Phase II trial of intravenous artesunate will begin recruitment of patients in September.

30 Aug 2007

Indevus submits new drug application for NEBIDO

Indevus Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism.

29 Aug 2007

Genta and Emisphere Technologies file investigational new drug exemption

Genta Inc. and Emisphere Technologies, Inc. have jointly announced the submission of an Investigational New Drug Exemption (IND) to the Endocrinologic and Metabolic Drugs Division of the U.S. Food and Drug Administration (FDA) for a new drug known as G4544.

2 Aug 2007

Impact of food-cancer drug interactions

A commentary in the Journal of Clinical Oncology (JCO) urges researchers to explore an intriguing approach to reduce the dose, and therefore the cost, of oral targeted cancer therapies.

18 Jul 2007

Biota and MedImmune announce clinical trial for respiratory syncytial virus antiviral drug

Biota Holdings Limited and MedImmune Inc. today announced the start of a Phase Ia clinical trial for their respiratory syncytial virus (RSV) antiviral drug, BTA9881, with the goal of providing a treatment for RSV-infected infants and adults.

17 Jul 2007

Baxter presents findings from the ADAPT study

Baxter Healthcare Corporation has announced the presentation of findings from the ADAPT (Analysis of Data from ADVATE Prospective Trials) study program database showing a statistically significant relationship between the duration of time spent with factor VIII blood levels below one international unit per deciliter (1 IU/dL, one percent of normal factor VIII level) and an increase in the annual bleed rate in people with hemophilia A.

11 Jul 2007

Experimental Alzheimer's drug begins clinical trials

A drug based on the design of a Purdue University researcher to treat Alzheimer's disease began the first phase of human clinical trials this week.

23 Jun 2007

Inherited genes linked to toxicity of leukemia therapy

St. Jude investigators have discovered inherited variations in certain genes that make children with acute lymphoblastic leukemia (ALL) susceptible to the toxic side effects caused by chemotherapy medications.

23 Jun 2007

Solvay Pharmaceuticals submits supplemental NDA for AndroGel

Solvay Pharmaceuticals, Inc., has announced that it submitted a supplemental New Drug Application (sNDA) for AndroGel (testosterone gel) 1% CIII to the U.S. Food and Drug Administration (FDA) for treatment in male adolescents ages 13-17 years old with primary or secondary hypogonadism.

17 Jun 2007

Peregrine Pharmaceuticals to initiate new Bavituximab HCV trial

Peregrine Pharmaceuticals has announced it has filed a new clinical trial protocol with the FDA to study bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV).

18 May 2007

Inherited variations in certain genes linked to toxicity of leukemia therapy

Investigators at St. Jude Children's Research Hospital have discovered inherited variations in certain genes that make children with acute lymphoblastic leukemia (ALL) susceptible to the toxic side effects caused by chemotherapy medications.

15 May 2007

Insulin therapy shown to treat early experimental diabetic retinopathy

Researchers presented study results that indicate that subconjunctivally delivered insulin ameliorates degenerative and inflammatory responses in diabetic rat retinas.

11 May 2007

BEMA Fentanyl demonstrates substantial transmucosal delivery

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the results of a 12 subject, crossover study comparing the absorption of fentanyl from both single and multiple BEMA? Fentanyl discs, as well as oral and intravenous doses of fentanyl.

8 May 2007

Recommended doses of ginseng, ginko biloba do not interfere with drug absorption

Recent findings that the widely-used herbal supplement Saint John's wort could dramatically affect the absorption and metabolism of many prescription and non-prescription drugs raised concerns that other popular herbal supplements might cause similar changes, thus significantly altering drugs, therapeutic or toxic effects.

2 May 2007

Baxter Healthcare presents phase I inhaled insulin study results

Baxter Healthcare Corporation announced results of a Phase I study that evaluated pulmonary insulin produced with Baxter's PROMAXX microsphere technology and administered using a small, standard dry powder inhaler.

24 Apr 2007

Viventia Biotech announces results of Proxinium antibody in combinaton with chemotherapy and radiation

Viventia Biotech has announced results of in vitro cytotoxicity and in vivo pharmacokinetic studies conducted to evaluate the potential for combining its phase III anti-cancer antibody therapeutic, Proxinium, with first-line standard of care therapy for squamous cell carcinoma of the head & neck (SCCHN).

19 Apr 2007