Malaysia's Premier Analytical Laboratory Specializing in Pharmaceutical Testing

Alcoax Laboratories Sdn. Bhd.
Alcoax Laboratories Sdn. Bhd.
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    • Home
    • Analytical Testing
    • Standards
    • Dossier Registration
    • Contact Us
    • Industries
    • Bioequivalence Support
    • Flagship Services
  • Home
  • Analytical Testing
  • Standards
  • Dossier Registration
  • Contact Us
  • Industries
  • Bioequivalence Support
  • Flagship Services

Bioequivalence Support

Alcoax has the capability and offers a ‘comprehensive assessment’ of your test product which can add value to your own evaluation and improve your confidence in cracking bioequivalence studies against the reference product. 

Following are the various services we offer

Risk assessment of prototype for BA/BE studies

In-vitro assessment studies to predict right formulation

Finding the discriminatory dissolution media

Exploring Bio-relevant media

F2 value matching for biowaivers on lower strengths

Statistical assessment of similarity (Other than F2 approach)

Statistical assessment of failed BE studies & optimization of product

Biowaiver support studies for BCS class 1 & 3 products

CRO Selection/CRO Screening

BE Study Protocol Design and Review

Study cost optimization / negotiation

Study Monitoring / Audit

Review of PK/Stat and Final Reports

Detailed assessment of failed BE & recommendations for passing

Download an example assessment report

Files coming soon.

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Experts in Nitrosamine Testing and Regulatory Compliance

Welcome to Alcoax Laboratories Sdn. Bhd. A MS ISO/IEC 17025:2017 accredited laboratory.