Properties of Drug Substance

McPhiUips in M. E. Goldberg, ed.. Pharmacological and Biochemical Properties of Drug Substances, Vol. 1, American Pharmaceutical Association,... 

JI Wells. Pharmaceutical Preformulation The Physicochemical Properties of Drug Substances. Chichester, England Ellis Horwood LTD, 1988, pp 209-210. 

The new millenium professional pharmacist with rigorous training in the scientific and clinical properties of drug substances and pharmaceutical formulations should be well able to dispassionately evaluate bioe-quivaleny data and give an objective, professional opinion as to validity of data purported to demonstrate generic bioequivalence. 

J. I. Wells, Pharmaecutical Preformulation. The Physicochemical Properties of Drug Substances, Halsted Press, New York, 1988. 

Change wavelength Move to the optimum wavelength for lamp power/absorption of drug substance Wavelength cut-off, spectral properties of drug substance, instrument wavelength precision robustness... 

The physicochemical characteristics of raw materials play an important role in content uniformity and bioavailability. Therefore, bioavailability of the drug over time must be thoroughly investigated before any significant changes are made. Once the physicochemical properties of drug substances (e.g., particle size of raw materials) can influence the availability and clinical effect of a product, the main characteristics of raw materials should be considered in a validation program. The... 

Properties of Drug Substances Dependent on the Solid State... 

The substantial research focus on the crystal structures of drug substances that has developed over the past decade [l-5a,b] has led to extensive interest in any modification of the properties of drug substances whose physical properties are less than desirable. Within this context, the advances being made in the areas of polymorphism and solvatomorph-ism have been amply documented [6-9]. 

Some physical properties of drug substances are important to the selection of the manufacturing platform itself. For example, if the drug has low density or if it... 

Drug Properties. In keeping with the QbD concept, the physicochemical and biopharmaceutical properties of drug substance should be characterized for a better... 

Wells, J.I. Pharmaceutical Preformulation—The Physicochemical Properties of Drug Substances Ellis Horwood Chichester, UK, 1988. 

Physicochemical properties of drug substance, including rationale for selection of polymorphic and salt form, if applicable... 

Wells JI. Pharmaceutical preformulation. The physicochemical properties of drug substances. Chichester, UK Ellis Horwood Ltd, 1988 219. 

Table 1 Some Important Properties of Drug Substances...

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