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A Summary of Pharmacokinetic Principles for ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists at PDG are also pharmacokinetic (PK) consultants. Proper design and placement of your PK studies is critical. Simply put (using the case of ANDAs), the regulations require the applicant to use ‘the most accurate, sensitive, and reproducible approach available among those set forth’.

Many of us recall the incident in the early 2000s, when FDA called the data of a well-known CRO into question. Affected were approvals and applications spanning a four-year period. The result was FDA issuance of over a thousand notifications to sponsors, noting significant concerns regarding the validity of the results within their applications.

FDA offered options to the companies which included repeat of the bioequivalence studies, re-assay of study samples at a different bioanalytical facility, or commissioning of a scientific audit by a qualified independent expert, who is knowledgeable in the area of bioequivalence studies and bioanalytical data.

PDG® conducted a number of the noted scientific audits and has designed a multitude of BA/BE studies for a variety of applications. We routinely source, qualify and oversee the activities of CROs.

Click here to read more about PK studies and their varied applications in drug development.

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Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration...
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