Formulation and Analytical Development for Low-Dose Oral Drug Products - Группа авторов
| Автор: | Группа авторов |
| Издательство: | John Wiley & Sons Limited |
| Серия: | |
| Жанр произведения: | Медицина |
| Год издания: | 0 |
| isbn: | 9780470386354 |
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.