Columbia, MD, United States
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PubMed | Independent Pharmacokinetics Consultant, Inc formerly Columbia Laboratories, BioMedical Computer Research Institute and ABC Laboratories
Type: | Journal: Clinical pharmacology in drug development | Year: 2016

Lidocaine vaginal bioadhesive gel is being developed as a local anesthetic for use in minimally invasive outpatient gynecological procedures and was investigated in single-dose and multiple-dose studies in healthy young adult women. Lidocaine doses of 2.5%, 5%, and 10% (w/w) were administered, and parent drug and metabolites monoethylglycinexylidide and glycinexylidide were measured in plasma. Lidocaine was absorbed through vaginal tissue and into the systemic circulation in a dose-proportional manner, and there was little systemic accumulation. Plasma concentrations were 10- to 20-fold lower than concentrations obtained after administration of intravenous lidocaine used to treat arrhythmic activity, thus demonstrating a wide safety margin for a vaginal lidocaine product.

News Article | November 24, 2016

Pharmaceutical manufacturers and developers of all extents, but chiefly the leading international pharmaceutical companies, now regularly outsource many functions and tasks earlier thought-to-be in-house principal proficiencies. The primary nature of the pharmaceutical industry has transformed as process efficiencies and cost management have become vital for persistence. Outsourcing has developed as an industry trend, and now comprises the full range of corporate activities –from screening and lead identification to toxicology and several other processes like preclinical studies, clinical trials, manufacturing, and marketing at all scales. Pharmaceutical outsourcing has proven effective at deducting infrastructure and operational expenses. However, the pharmaceutical industry during this duration has realized a significant decrease in its new product pipelines due to reduced R&D efforts. This has triggered many organizations to device further internal cut-backs and escalate their outsourcing, as a way to decrease capital and payroll overheads. This economics-driven growth in pharmaceutical outsourcing has, in some ways, contributed to reduced long-term industry efficiency. But even though pharmaceutical outsourcing is eventually demonstrated not to be cost-effective in terms of supporting new product R&D and innovation, outsourcing will carry on to experience growth. Often it is the only alternative accessible to pharmaceutical companies that must adjust to lower profits due to indisposed R&D pipelines and products going off-patent. Global pharmaceutical outsourcing market will endure escalating during the forecast period, but at an increased rate than in the past. Request TOC (desk of content material), Figures and Tables of the report: Improving efficiencies, reducing costs, ensuring business continuity, better access expertise, reducing staff, allowing staff to focus on the core competency, mitigating risk through using specialists count are few of the drivers associated with the  Global pharmaceutical outsourcing market. While the best aspects probable to generate capacity (manufacture) restraints are economics driven, including the inability to hire experienced technical staff, facility constraints, and physical capacity of the equipment. The pharmaceutical outsourcing trend started off with the outsourcing of non-core support functions such as HR finance, and IT. In pharmaceuticals, outsourced contract research and contract manufacturing have become the standard for several pharmaceutical companies. Asian contract research organizations (CROs) and manufacturing organizations (CMOs) compete with their European and North American counterparts in a worldwide pharmaceutical outsourcing marketplace. During the forecast period, pharmaceutical outsourcing market will continue to witness a shift toward developing biopharmaceuticals rather than drugs, as these products offer better profits and protection against ultimate generic competition. Many profitable antibody products and recombinant protein are coming off-patent. Over the forecast period, global pharmaceutical outsourcing market will witness dramatic growth, likely a doubling, in the amount of biopharmaceutical products as bio better, biosimilar, and biogenetic varieties of current products enter world markets. Depending on the geographic region, global pharmaceutical outsourcing market is segmented into five key regions: North America, Latin America, Europe, Asia-Pacific, and the Middle East & Africa. Considerable of the growth in global pharmaceutical outsourcing market in the previous decade, mostly the rapid and dramatic growth, has occurred in low and middle-income economies, particularly India and China. Moreover low and middle-income economies proposing lower costs, these economies have their own briskly increasing native pharmaceutical industries and markets. Numerous of the leading global pharma companies invest billions in forming their own R&D centers and/or outsourcing to CMOs/CROs in these low and middle-income economies. That has provided a corporate presence and access in these promptly developing markets. Nevertheless, as the wage gap in these emergent economies narrows, employment and other outsourcing costs are growing. In the future, leading global pharma companies will move outsourcing to lesser-developed nations. By the same time, Indian and Chinese firms will shift to providing on advance quality and technology, instead of price. Some of the key players in global pharmaceutical outsourcing market are ABC Laboratories, Aenova, Alkermes plc, Associates of Cape Cod Inc., BioPharma Solutions, Catalent Pharma Solutions, Coldstream Laboratories Inc., Covance Inc., Cytovance Biologics, Inc., Dalton Pharma Services, DPT Laboratories, Emergent BioSolutions Inc., Fresenius Kabi, Grand River Aseptic Manufacturing (GRAM), Halo Pharmaceutical, IGI Laboratories, Lyophilization Technology, Inc., Metrics Inc., Mikart, Inc., Patheon, Inc., Pillar5 Pharma Inc., and Velesco Pharma and several others.

Wolf J.R.,ABC Laboratories | Zhao T.,Sunshine Chemlab Inc. | Landorf C.,Brewer Scientific Inc. | Dyer D.J.,ABC Laboratories | Dyer D.J.,Southern Illinois University Carbondale
Liquid Crystals | Year: 2014

A series of laterally substituted noncentrosymmetric hydrogen-bonded liquid crystalline polymers which incorporate stilbazole acceptor units, alkyl or ethylene glycol linkers units, and benzoic acid or phenol donor units were prepared and investigated for their hydrogen bonding behaviour and phase transitions. Fourier transform infrared (FTIR) indicated that these polymers possess strong intermolecular donor-acceptor hydrogen bonding. These polymers have lower melting points than their non-substituted analogue, and some of the polymers are mesomorphic. © 2014 © 2014 Taylor & Francis.

Wolf J.R.,ABC Laboratories
Journal of Labelled Compounds and Radiopharmaceuticals | Year: 2016

Radiolabeled compounds are invaluable tools used to study synthetic and biological processes. Radiolabeled polymers find uses in mechanistic pathway elucidation, bioincorporation studies, biodegradation studies, and drug delivery applications. This literature review examines the syntheses (or biosyntheses), physical properties, and applications of radiolabeled polymers which contain covalently bound tritium and carbon-14 atoms. © 2016 John Wiley & Sons, Ltd.

Wolf J.R.,ABC Laboratories
Liquid Crystals Reviews | Year: 2014

Hydrogen bonding has been extensively used to create the mesogenic core of calamitic liquid crystals. While the field of polymeric hydrogen-bonded liquid crystals has been extensively studied, most of the research has been devoted to side chain hydrogen-bonded polymeric liquid crystals with far less effort devoted to the study of main chain hydrogen-bonded liquid crystals despite the variety of liquid crystalline (LC) phases they possess. In this review, centrosymmetric and noncentrosymmetric main chain hydrogen-bonded polymers are discussed with an emphasis on the structure/property relationships and the variety of LC phases observed in the resulting polymers. © 2014 Taylor & Francis.

Chen N.,Celgene | Wen L.,ABC Laboratories | Lau H.,Celgene | Surapaneni S.,Celgene | Kumar G.,Celgene
Cancer Chemotherapy and Pharmacology | Year: 2012

Purpose: Assessment of the absorption, metabolism and excretion of [ 14C]-lenalidomide in healthy male subjects following a single oral dose. Methods: Six healthy male subjects were administered a single 25 mg oral suspension dose of [ 14C]-lenalidomide. Blood (plasma), semen and excreta were collected. Mass balance assessments were done by radioactivity measurements. Metabolite profiling and quantitation were accomplished using liquid chromatography with mass spectrometric and radiochemical detection. Results: [ 14C]-Lenalidomide was rapidly absorbed (T max 0.77-1.0 h), and the levels declined with a terminal half-life of approximately 3 h, with similar profiles for total blood and plasma radioactivity as well as plasma lenalidomide. The whole blood to plasma radioactivity exposure levels were comparable, suggesting equal distribution between plasma and blood cells. On average, 94% of the administered radioactivity was recovered within 10 days, with >88% recovered within 24 h. Urinary excretion was the primary route of elimination (90% of radioactive dose), with minor amounts excreted in feces (4%). Semen contained a small amount of the radioactive dose (0.0062%). Lenalidomide was the primary radioactive component in plasma (92% of the [ 14C]-area under the concentration-time curve) and urine (>90% of the radioactivity in urine). The remaining radioactivity was composed of primarily two metabolites: 5-hydroxy-lenalidomide and N-acetyl-lenalidomide, each accounting for less than 5% of the total radioactivity as well as lenalidomide levels in plasma and excreta. Conclusions: In summary, following oral administration, lenalidomide is highly absorbed and bioavailable, metabolized minimally, and eliminated predominantly via urinary excretion in the unchanged form in humans. © 2011 The Author(s).

Grant J.,ABC Laboratories | Rodgers C.A.,ABC Laboratories | Chickering C.D.,ABC Laboratories | Hill S.J.,DuPont Company | Stry J.J.,DuPont Company
Journal of AOAC International | Year: 2010

An analytical method is presented for the determination of chlorantraniliprole residues in crops. Chlorantraniliprole residues were extracted from crop matrixes with acetonitrile after a water soak. The extracts were passed through a strong anion-exchange (SAX) SPE cartridge stacked on top of a reversed-phase (RP) polymer cartridge. After both cartridges were rinsed and vacuum-dried, the SAX cartridge was removed, and chlorantraniliprole was eluted from the RP polymer cartridge with acetonitrile. The acetonitrile eluate was evaporated to dryness, reconstituted, and analyzed using an LC/MS/MS instrument equipped with an atmospheric pressure chemical ionization source. The method was successfully validated at 0.010, 0.10, and 10 mg/kg for the following crop matrixes: potatoes, sugar beets (tops), lettuce, broccoli, soybeans, soybean forage, tomatoes, cucumbers, oranges, apples, pears, peaches, almonds (nutmeat), rice grain, wheat grain, wheat hay, corn stover, alfalfa forage, cottonseed, grapes, and corn grain. The average recoveries from all crop samples fortified at the method LOQ ranged from 91 to 108%, with an overall average recovery of 97%. The average recoveries from all crop samples fortified at 10 times the method LOQ ranged from 89 to 115%, with an overall average recovery of 101%. For all of the fortified control samples analyzed in this study, the overall average recovery was 99%.

Koch D.A.,ABC Laboratories | Clark K.,Morse Laboratories LLC | Tessier D.M.,DuPont Company
Journal of Agricultural and Food Chemistry | Year: 2013

Stable isotope internal standards are useful in correcting for matrix effects and instrumental variability when environmental samples such as wastewaters and biosolids are analyzed by mass spectral methods. This paper reports the use of deuterium-labeled analogues of eight pyrethroid insecticides to improve accuracy for the analysis of environmental samples by negative chemical ionization gas chromatography with mass spectrometric detection (NCI-GC-MS). Data for the analysis of effluent water from wastewater treatment facilities are presented which demonstrate that the method is rugged and capable of achieving limits of quantification (LOQs) as low as 0.5 ng/L (ppt), with individual recoveries within the range of 81-94% for those compounds with minimal control background concentrations. In addition, an alternate use of the deuterium-labeled standards is proposed for the determination of method recoveries at low levels that would normally have been precluded due to background pyrethroid levels present in environmental samples being used for control fortifications. © 2013 American Chemical Society.

Dyer D.J.,Southern Illinois University Carbondale | Wolf J.R.,Southern Illinois University Carbondale | Wolf J.R.,ABC Laboratories
Macromolecular Research | Year: 2014

The syntheses and characterization of a series of noncentrosymmetric main chain hydrogen bonded macromolecules are described, which contain 4-pyridone hydrogen bond acceptor units. These macromolecules possess strong intermolecular hydrogen bonding as demonstrated using attenuated total reflectance (ATR) FTIR. The phase transitions of the macromolecules depend on the identities of the hydrogen bond donor, lateral substituent, and linker chain. © 2014 The Polymer Society of Korea and Springer Sciene+Business Media Dordrecht.

Dyer D.J.,Southern Illinois University Carbondale | Wolf J.R.,Southern Illinois University Carbondale | Wolf J.R.,ABC Laboratories
Macromolecular Research | Year: 2014

The syntheses and characterization of three noncentrosymmetric main chain hydrogen bonded macromolecules which incorporate diethyl-[4-(pyridin-4-ylazo)- phenyl]-amine hydrogen bond acceptor units are reported. These macromolecules participate in strong intermolecular hydrogen bonding as demonstrated using attenuated total reflectance (ATR) FTIR. The phase transitions of these macromolecules depend on the identity of the hydrogen bond donor. Mixtures of these azo-stilbazole macromolecules with noncentrosymmetric hydrogen bonded liquid crystalline macromolecules possess nematic liquid crystalline phases when the concentration of the azo-stilbazole macromolecule is ≤ 50 mol%. © 2014 The Polymer Society of Korea and Springer Sciene+Business Media Dordrecht.

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