Detail E-Book
Pharmaceutical Stress Testing
Pengarang: Steven W. Baertschi
Edisi: 2
ISBN/ISSN: 0-8247-4021-1
Penerbit: Taylor & Francis Group
Tahun Terbit: 2005
Tempat Terbit: Boca Raton, Florida
Judul Seri: Pharmaceutical Stress Testing
Bahasa: English
No. Panggil: PHA
GMD: Electronic Resource
Catatan
Pharmaceutical stress testing plays a critical role in the drug development process by serving as the primary tool to predict stability-related problems, elucidate degradation pathways, identify degradation products, and validate the stability-indicating capability of analytical methods. Driven by increased regulatory scrutiny regarding impurities from international harmonization efforts and the pharmaceutical industry's need to accelerate time-to-market, stress testing has evolved from an empirical practice into a rigorous scientific approach. This comprehensive reference work benchmarks current best practices among experienced pharmaceutical scientists, addressing fundamental questions regarding appropriate stress conditions—such as temperature increments, humidity, pH ranges, oxidation, and photostability—alongside key chemical concepts including mass balance, photostability, oxidative susceptibility, and the underlying chemistry of drug degradation. By examining both the physical and chemical intrinsic stability characteristics of small molecule pharmaceuticals and solid oral dosage forms, the text provides a practical guide for researchers to design, execute, and interpret forced degradation studies effectively, ensuring the safety, efficacy, and quality of new drug substances and products.
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