Accutest conducts Bioavailability & Bioequivalence Studies (BA/BE).
These include studies with
- Fasted / Fed Conditions
- Immediate / Modified-release Preparations
- Interaction Studies
- Various Routes of Administration
- Healthy Volunteers / Special Population

At each of our centers, an Analytical unit is complemented by a Clinical Pharmacology unit (CPU) providing clients with the complete package for BA/ BE studies. However the sponsor can opt either for analytical services or clinical conduction in individually.

The Analytical services offered by us can be utilized at any stage of the drug development process from formulation development through Phase 4 studies.

The objective of bioanalysis is to provide a quantitative measure of the active drug and/or its metabolite(s). Samples may be derived from cell culture media or from other biological matrices (plasma, serum or urine etc). An appropriate method/ technique is required to make these measurements. Selection of the correct technique may depend on the molecule's chemical nature, molecular weight, and structure.

All the three centers boast of Strong scientific and regulatory knowledge, automation & method development expertise combined with experienced analytical chemists & Pharmacologists
Our services include:

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Bioequivalency Studies
We quickly and accurately perform studies that compare pharmaceutical equivalents or alternatives for the purpose of establishing equivalent extents and equivalent rates of absorption.
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Method development & Validation
We have more than 80 validated methods developed by our team of scientists who have both the experience and expertise. These methods are applied by a highly skilled technical staff trained for use of the latest equipment such as LC MS/ MS (API-2000, 3000, 3200, 4000), Analytical Balance and GC with FID, ECD. View List of Validated Methods
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Pharmacokinetic Analysis (PKA)
Assessment of the Pharmacokinetics of lead compounds early in the drug development cycle provides data that enables prediction of metabolism or PK in humans. We conduct comprehensive statistical data analysis using the industry standard WinNonLin™ and SAS™ and integrate our PKA reports for ease of regulatory submission.
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Clinical PK/ Bioavailability Studies
Accutest conducts Clinical Bioavailability studies throughout the major stages of drug development. These studies measure the rate of distribution and elimination from the body, measure the amount of drug available at the therapeutic site and provide data that help establish appropriate dosage and dose frequency.
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