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You are a pharmaceutical scientist employed by a pharmaceutical company that is developing a compound called DDZ. The structure of DDZ is provided below along

You are a pharmaceutical scientist employed by a pharmaceutical company that is developing a compound called DDZ. The structure of DDZ is provided below along with a table of general properties.

DDZ is currently undergoing Phase 1 clinical evaluation in humans. You are part of the scientific team developing DDZ and you are responsible for overseeing issues related to pharmaceutical analysis, preformulation screening, and pharmacokinetic evaluation of DDZ. Please answer the following questions

Pharmaceutical Analysis

Recommend analytical METHODS for the quantitative determination of the DDZ. Support your choice by explaining WHY you are making that recommendation.

DDZ is to be separated from plasma with a solid phase extraction technique. Outline a solid phase extraction PROCEDURE for this drug from the plasma. (Please remember to mention type of solid phase, solvents,)

Suggest an HPLC method for the quantitative determination of DDZ. (Please remember to mention type of stationary phase, mobile phase, detector..)

There are several criteria used to validate an analytical method. Mention one of these criteria and provide its definition and how it is measured or reported.

Preformulation Screening

The figure below is a plot of Molar Solubility (aqueous) vs. pH for DDZ. Based on this figure, please answer questions 5 through 7.

What is the chemical nature of DDZ?

What is the pKa of DDZ?

Calculate the molar solubility at pH 1.8.

Pharmacokinetic Evaluation

Drug DDZ is being developed by your company to treat hypertension. As a pharmaceutical scientist, you have been asked to design a dosing regimen (IV Bolus dose) of Drug DDZ to maintain therapeutic plasma concentrations throughout the day. The target therapeutic range is 20 100 ng/ml.

The Figure below is plot of mean plasma concentration vs. time following administration of an IV bolus dose (12 mg) of DDZ in humans.

Please answer questions h though k

Calculate the pharmacokinetic parameters for DDZ (Cl, VD, k, t1/2). Make sure to include units for each parameter.

Assuming that DDZ was to be administered on a twice daily (every 12 hours), calculate a dose (IV bolus) that would maintain plasma levels within the target therapeutic range at steady state. Based this answer on the parameters you calculated in question h above.

If you had to explain to your colleagues the meaning of linear pharmacokinetics, what would you tell them?

Assuming DDZ was administered as a once daily dose (IV bolus every 24 hours), would you expect plasma levels to accumulation at steady state? Please provide a brief explanation.

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