Stability of drugs

Davies, O. L., and Hudson, H. E., Stability of Drugs—Accelerated Storage Tests, Chapter 21B in Statistics in the Pharmaceutical Industry, C. R. Buncher and J.-Y. Tsay, Eds., Marcel Dekker, 1994. 

Shen M, Xiao Y, Golbraikh A, Gombar VK, Tropsha A. Development and validation of k-nearest-neighbor QSPR models of metabolic stability of drug candidates. J Med Chem 2003 46 3013-20. 

Recent developments in drug discovery and drug development spurred the need for novel analytical techniques and methods. In the last decade, the biopharmaceutical industry set the pace for this demand. The nature of the industry required that novel techniques should be simple, easily applicable, and of high resolution and sensitivity. It was also required that the techniques give information about the composition, structure, purity, and stability of drug candidates. Biopharmaceuticals represent a wide variety of chemically different compounds, including small organic molecules, nucleic acids and their derivatives, and peptides and proteins. 

H. Nogami, M. Horioka, Studies on Decomposition and Stabilization of Drugs in Solution. VI. Chemical Kinetic Studies in Aqueous Solution of Diphenhydramine , J. Pharm. Soc. Jap. (Yakugaku Zasshi) 1961, 81, 79 - 83. 

Yoshioka, S. and Stella, V.J., Stability of Drugs and Dosage Forms, Kluwer Academic, New York, 2002. 

Importance of functional groups in determining stability of drugs... 

In Section 4.10, you have already seen that, just by introducing a new functional group on a penicillin molecule, the acid stability of penicillins can be improved remarkably, and similarly the introduction of bulky functional groups in penicillin offers stability against (3-lactamases. Thus, functional groups play a vital role in the stability of drugs. 

QID, Bracketing and matrixing designs for stability of drug substances and drug products, ICH, Brussels. 

EFFECT OF PACKAGING ON STABILITY OF DRUGS AND DRUG PRODUCTS... 

Rationale for Concern with Stability of Drugs and Drug Products... 

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