Study Planning & Protocol Development/Revision
16703
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Study Planning & Protocol Development/Revision

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Clinical & Bioanalytical Phase

Study Planning & Protocol Development/Revision

A well-designed study protocol is the first and key point in the success of the BE study. The BE protocol depends on multiple factors such as drug physicochemical and pharmacokinetic characteristics, formulation type, relevant health authority regulations, study design, bioequivalence criteria and the type of volunteers required etc.
Many BE studies usually fail to meet the BE criteria or even may be rejected by the regulatory authority due to inappropriately designed protocol.
Our experts will work with the CRO in the protocol development to assures its compliance with all relevant guidelines and its suitability to the drug molecule regarding study design, sample size, proposed statistical approach, sampling schedule, clinical and bioanalytical plans

as well as all other scientific and regulatory aspects (e.g., detection and dealing with outliers and missed samples)