Quantitative determination of humanized monoclonal antibody rhuMAb2H7 in cynomolgus monkey serum using a Generic Immunoglobulin Pharmacokinetic (GRIP) assay.

Preclinical pharmacokinetic (PK) assays are important to help evaluate the safety and efficacy of a potential biotherapeutic before clinical studies. The assay typically requires a biotherapeutic-specific reagent to minimize matrix effects especially when the host species are non-human primates such as cynomolgus monkeys and the biotherapeutic is a humanized monoclonal antibody (MAb). Recombinant humanized mAb 2H7 (rhuMAb2H7) binds to the extracellular domain of CD20 that is expressed on B cells and results in B cell depletion.

Evaluation of total IGF-I assay methods using samples from Type I and Type II diabetic patients.

Measurements of circulating insulin-like growth factor-I (IGF-I) levels are an important part of many studies on growth and development. Circulating IGF-I levels are growth hormone (GH) dependent and are also impacted by age, gender, nutritional status and disease. Moreover, IGF-I is the main pharmacodynamic marker of GH activity.

A pilot study of the CY-1899 T-cell vaccine in subjects chronically infected with hepatitis B virus. The CY1899 T Cell Vaccine Study Group.

Clinical observations suggest that eradication of the hepatitis B virus (HBV) is immune-mediated. Vigorous cytotoxic T lymphocyte (CTL) activity directed at HLA class I-bound viral epitopes are detected during acute hepatitis B, but not in chronic hepatitis B carriers. A CTL epitope derived from the hepatitis B core protein amino acids 18-27 has been incorporated into a vaccine also comprised of a T-helper cell epitope and 2 palmitic acid residues (CY-1899).

Pharmacodynamics of recombinant human DNase I in serum.

Recombinant human deoxyribonuclease I (rhDNase) may be an effective therapeutic for the treatment of systemic lupus erythematosus (SLE). The pharmacodynamics of rhDNase in serum was investigated using two activity assays: one based on hydrolysis of a radiolabelled phage DNA and the other based on hydrolysis of human chromatin. The concentration of endogenous immunoreactive DNase in sera from 16 normal subjects was 3.

Anaesthesia for gynaecological laparoscopy--a comparison between the laryngeal mask airway and tracheal intubation.

In a single-blind, randomised, controlled study, we compared two anaesthetic techniques in 60 patients undergoing gynaecological laparoscopy. In the first group, ventilation was controlled, after paralysis and tracheal intubation. In the second group, a laryngeal mask airway was inserted and spontaneous or assisted ventilation allowed.

The Vater association and spinal dysraphia.

We here present a hereto previously undescribed association of occult spinal disorders of the distal spinal cord/filum in the Vater association. We present 6 patients who were diagnosed as having the Vater association who subsequently presented with occult spinal disorders, primarily lipomas of the filum/conus complex with or without subcutaneous lipomas. Uniformly the spinal cord was tethered to the lipoma/filum complex.

Suxamethonium--the relation between dose and response.

In a study which involved 120 adult patients, the ED95 of suxamethonium was shown to be 0.51 mg/kg, using an electromyographic technique. Marked individual variation in response was noted, for example a dose of 0.