Exelion Bio-Pharmaceutical Consultancy B.V.

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Biopharmaceutics

biopharmaceuticsFor every pharmaceutical drug product characterization is important to quarantee the quality and reproducibility to allow for a robust performance in patients. This characterization is normally done in-vitro with conventional pharmacopeial tests, such as content uniformity and well-described dissolution tests. For advanced dosage forms a simple quality performance test is often not possible. Sometimes such a test will simply take too long; if an implant should work for 2 years in-vivo it is not an adequate approach to do a quality test of a batch for 2 years before it can be used. Or it is difficult to extrapolate the behavior in vivo on the basis of a model in the lab. Exelion has unique expertise with all kinds of oral, (trans)dermal, implantable and injectable controlled release dosage forms to establish an adequate relation between performance in-vitro models and in-vivo both in animals as well as in humans. This is a highly valid instrument during the development of such a dosage form, during pharmacokinetic testing in-vivo and for final quality control purposes.

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