Services

Driving Healthcare to the ultimate

In-Vivo Bioequivalence/Bioavailability Studies

Comprehensive Bioavailability /Bioequivalence Solutions

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  • Protocol design and development

  • Data management

  • Phase I trial operation and management

  • Pharmacokinetic research

  • Bio-analysis

  • Statistical analysis

  • Report production

Bio-analytical services

Full Bio-analytical Solutions

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  • Method development from scratch or fine-tuning of existing methods.

  • Method Validation according to validation protocols compliant with ICH, FDA and EMA requirements.

  • Method transfer from/to your laboratory, in accordance with customized protocol including analyst training if needed.

  • Analysis of drug and metabolites in different biological fluids.

  • In-vitro in-vivo correlation (IVIVC).

  • State - of - the art technologies:

    • UPLC-TQ-MS

    • UPLC-TQD

Bio-waivers and comparative in-vitro dissolution studies

  • Pharmaceutical services including analytical method development and method validation.

  • Full dissolution profiles and studies' report that conforms to standards and regulatory guidelines.

  • State - of - the art technologies:

    • UPLC-PDA

    • HPLC-PDA/IR/Fluorescence

Stability Studies

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  • ICBR offers stability testing and storage programs for a wide range of pharmaceuticals to meet international guidelines. Comprehensive analytical method development and validation capabilities support testing of API's, finished products, and compatibility of formulation components.

  • Stability chambers (Votsch) are available; all chambers are continuously monitored by automated monitoring systems with full back-up power and water supplies. ICBR performs accelerated stability and long-term stability studies.

Quality Assurance and auditing services

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  • Building Quality Systems for science based institutions and CROs.

  • Performing Quality Audits.

  • Establishing Quality Assurance and Quality Control Standard Operating Procedures aligned with FDA / EMA / National regulatory authorities as well as ICH/ GCP and GLP standards and requirements.

Training services

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  • Well-trained clinical site staff is a key factor in ensuring the success of clinical trials and other health research studies. ICBR's dedicated training professionals and project staff work together to provide support staff with effective and engaging training so that they are equipped with critical knowledge and skills.

  • Training Courses:

    • Protocol writing

    • Good Clinical Practice (GCP)

    • Data Management

    • Analytical procedures

    • Quality Assurance and quality control

Preclinical studies

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  • Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic and safety information. Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo (animal) experiments,.

    Much like for clinical trials, there are certain types of trials that have to be done, such as toxicology studies in most cases, Don't get too worked up on too many preclinical trials that may not be necessary but make sure to consult with experts who can help you decide, which trials you should do and if you are ready to move into clinical stage. At Profile we have a team of experts who can advice you on such questions and who will help you with the transition into clinical trials. Contact us to start the discussion.

  • Address

    Plot No. 10, Block No. 12018, North Industrial Zone, El-Obour City, Egypt

  • Phone

    +202-4489-1252

  • Email contact

    info@icbr.info

  • Website

    www.icbr-egypt.com