Topic FDA

Products FDA

UHPLC-MS for high resolution applications

Is your current HPLC system limiting you? Do you want more sensitivity and confidence in your data than with UV detection? This offer is for you! more

Melamine Analysis in Pharmaceutical Industry with SeQuantTM ZIC®-HILIC columns from Merck

The FDA issued "Guidance for Pharmaceutical Industry" recommends using Merck's SeQuantTM ZIC®-HILIC HPLC for determination of melamine contamination in pharmaceutical raw materials more

Catalogues FDA

Accurate, efficient and flexible sample preparation with the HAMILTON MICROLAB® 600 Series

The MICROLAB 600® is a high-precision syringe pump with a graphical user interface designed to quickly dilute and dispense liquids more

News FDA

• Genzyme gets Regulatory Approvals of Expanded Waterford Manufacturing Plant

  Genzyme, a Sanofi company, announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant.  With this approval, Genzyme has nearly doubled its ability to fill a more

• Ablynx receives milestone payment as collaborator receives IND approval for a nanobody in oncology

  Ablynx announced that it has received a €400,000 milestone payment from its collaboration with Novartis. The payment was triggered by the approval of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration for the Phase I clinical trial for a Nanobody® licensed to No more

• Agilent Technologies and FDA Collaborate to Improve Testing for Salmonella

  Agilent Technologies Inc. announced that it has entered into a Cooperative Research and Development Agreement with the U.S. Food and Drug Administration to develop new tools to detect and analyze pathogens in food. The joint R&D effort will also seek to improve DNA-based tools for confirming that se more

White papers FDA

• Outsourcing R&D Innovation takes on New Meaning
  

  Innovative drugs are the lifeblood of pharmaceutical companies, but the cost of developing them is rising to unsustainable levels. Pharma executives are already saying that as the economy falters, they foresee bleak prospects and mergers unless their companies get more innovative drugs into their pipelines. The clock is ticking on the race to increase productivity, as key patents worth a projected $30 billion in revenue will expire between 2010 and 2013, opening the floodgates to competition from generics, according to Barbara Ryan, an analyst at Deutsche Bank. This imperative is propelling increased outsourcing of R&D operations as companies trim overcapacity. more

• Predictor(TM) hERG Fluorescence Polarization Assay Kit performed on the PHERAstar/PHERAstar Plus
  

  The potential for cardiotoxic side-effects continues to challenge the development of small molecule based therapies. These intolerable side-effects are often precipitated by drug-induced long QT syndrome (LQT), which is often linked to blocking the human ether-a-go-go related gene (hERG) potassium channel. Although patch-clamp electrophysiology remains the gold standard for determining the interaction of compounds with the function of the hERG channel, radioligand displacement assays have proven to be a cost-effective initial alternative assay for hERG channel liability at early stages of compound development. more

• Interference and HAMA problems
  

  Immunoassays are bioanalytical methods based on antibodies. These include ELISA, EIA, RIA, Western blotting, protein arrays, lateral flow assays (immuno-chromatography), immunohistochemistry or immuno-PCR. Antibodies detect the substances (analytes) in immunoassays. This detection is always highly specific and only the analytes are detected and bound. This is the theory! Practically any antibody not only binds its analyte. It also binds several other substances, but with very different affinities. more

Publications FDA

• Development and validation of a highly sensitive method for the determination of abiraterone in rat and human plasma by LC‐MS/MS‐ESI: application to a pharmacokinetic study

  ABSTRACT A highly sensitive, rapid assay method has been developed and validated for the estimation of abiraterone (ART) in rat and human plasma with liquid chromatography coupled to tandem mass spectrometry and electrospray ionization in the positive‐ion mode. The assay procedure involves extrac more

• Lithium Modulates Cancer Cell Growth, Apoptosis, Gene Expression and Cytokine Production in HL-60 Promyelocytic Leukaemia Cells and Their Drug-Resistant Sub-clones

  Lithium has been an FDA-approved and preferred drug for the treatment of mood disorders for many years, and cumulative evidence has pointed towards its potential use as an anti-cancer agent. Previous studies in our laboratory have demonstrated that lithium induces apoptotic cell death in HL-60 promy more

• Prediction of Drug-Target Interactions and Drug Repositioning via Network-Based Inference

  by Feixiong Cheng, Chuang Liu, Jing Jiang, Weiqiang Lu, Weihua Li, Guixia Liu, Weixing Zhou, Jin Huang, Yun Tang Drug-target interaction (DTI) is the basis of drug discovery and design. It is time consuming and costly to determine DTI experimentally. Hence, it is necessary to develop comp more

Market studies FDA

• Puerto Rico Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: Puerto Rico is struggling to retain its reputation as a pharmaceutical manufacturing hub, with a number of plants found to be in breach of regulations and standards over recent years. Additionally, the flagging economy is expected to push skilled staff to emigrate, leaving fewer candidates more

• Thailand Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: Thailand is a moderately attractive pharmaceutical market for multinationals. On the positive side, rewards are potentially considerable, given the country’s epidemiological profile and the growing population numbers. However, the government’s stance on compulsory licences and regulatory a more

• FDA Approves Erivedge (Vismodegib) for Metastatic or Locally Advanced Basal Cell Carcinoma

  Introduction GlobalData, the industry analysis specialist, has released its new report, “FDA Approves Erivedge (Vismodegib) for Metastatic or Locally Advanced Basal Cell Carcinoma”. The report is an essential source of information on the approval of Erivedge by the US FDA. The report also provides more