<h1>Bioequivalence</h1> <h2>bioavailability</h2> <p>We have expertise in the following subject:</p> <ul> <li>fed bioequivalence</li> <li>bioavalability and bioequivalence</li> <li>bioequivalence and pharmacokinetics</li> <li>bioequivalence and statistics in clinical pharmacology</li> <li>guidancefor industry bioequivalence</li> <li>pharmaceutical bioequivalence</li> <li>pharmacokinetics bioequivalence</li> </ul> <ul> <li>bioavailability and bioequivalence</li> <li>bioavailability bioequivalence</li> <li>bioequivalence</li> <li>bioequivalence centre</li> <li>bioequivalence centres</li> <li>bioequivalence design</li> <li>bioequivalence guideline</li> <li>bioequivalence guidelines</li> <li>bioequivalence hplc</li> <li>bioequivalence pharmacokinetic</li> <li>bioequivalence problems</li> <li>bioequivalence review</li> <li>bioequivalence studies</li> <li>bioequivalence study</li> <li>bioequivalence testing</li> <li>bioequivalence waiver</li> <li>bioequivalent test</li> <li>clinical bioequivalence</li> <li>comparative bioequivalence</li> <li>fda bioequivalence</li> <li>fed bioequivalence studies</li> <li>formulation bioequivalence</li> <li>generic bioequivalence</li> </ul> <ul> <li>anmat bioequivalence</li> <li>anvisa bioequivalence</li> <li>emea bioequivalence</li> <li>fda bioequivalence</li> </ul>
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History of LBBM Research Clinical Trials
Staff of LBBM Bioequivalence
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Clinical Trial Research in Argentina
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Biomedical research Clinical Trial protocol writing Clinical Trials CRO Site Selection Drug distribution in Clinical Trials Biotechonolgy LBBM Bioanalisis Auditing Consultancy Clinical Research Trials
 

BIOANALYSIS PK-BIOTECH | BIOEQUIVALENCE

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  • Pharmacokinetic studies
  • Bioequivalence/bioavailability studies
  • GLP experience
  • Biotechnology-derived products

PK studies: Extensive experience in Phase I and II trials, single or multiple dosing, fast or fed conditions, special procedures like PBMC´s processing and handling, pharmacodinamic studies, data management using validated software (WinOnlin®).

Bioequivalence studies: working since 2001 on Bioequivalence studies for marketing authorization of the national industry, LBBM offers the organization of these kinds of trials, with a high database of healthy volunteers, experienced sites and bioanalysis laboratory.

GLP experience: LBBM staff has expertise in GLP standards, validation methods according to national requirements, analytical method development, and offers training of sites and laboratories for correct sample handling and processing

Biotech products: Given the large expertise of LBBM staff in molecular biology, we also offer for the studies involving Biotechnology-derived study medication (recombinant proteins, monoclonal antibodies, etc), quality control procedures, training in specific handling of these kinds of samples, auditing and consulting.

  

llbm At LBBM we have a tradition of working at the bench: many years on molecular biology and biotechnology and later developing and validating analytic methods for HPLC analysis. This allows us to also offer our clients a special expertise in all bio analytic steps that a trial needs, a complete handling of bioequivalence trials and a profound knowledge on biotech products (dossiers, methods, QA). llbm