Bioassay （or biological assay） is a biological testing procedure for determining the efficacy of a
pharmaceutically active substance in a formulated product or bulk material by observing their effects on
living animals (in vivo) or tissues (in vitro). In contrast to common physical or chemical methods,
bioassays produce detailed information about the biological activity of a drug substance.
Bioassays also include the detection of biohazards, the quality assessment of mixtures, their impact on the
surrounding environment, and the assessment of the environmental impact and safety assessment of new
technologies and facilities.
Creative Biolabs’s expertise in bioassay and the experience gained from our hundreds of projects have
enabled us to work closely with our clients to provide scientific and experimental expertise in the design
and implementation of tailored bioassays. The development, optimization, validation and performance of our
biological/potency assays are carried out in accordance with GMP regulations. Validation strategies are
based on international guidelines and recommendations (e.g., ICH, US-FDA, ISO, EMEA).
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