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- Springer 2013; US$ 159.00
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: â?¢ Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based... more...
- Wiley 2013; US$ 205.00
Systematically examining current methods and strategies, this ready reference covers a wide range of molecular structures, from organic-chemical drugs to peptides, proteins and nucleic acids, in line with emerging new drug classes derived from biomacromolecules. A leader in the field and one of the pioneers of this young discipline has assembled here... more...
- Elsevier Science 2013; US$ 174.95
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule... more...
- iSmithers Rapra Publishing 2013; US$ 130.00
Pulmonary drug delivery has been a rapidly expanding field, moving from the traditional propellant based metered dose inhaler delivery of small asthma drugs, to a broader landscape of new devices and novel drugs for local and systemic delivery. The field has greatly expanded yet the tools for pulmonary drug delivery systems have not kept pace with... more...
- Taylor and Francis 2013; US$ 356.00
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation... more...
- Taylor and Francis 2013; US$ 230.00
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach... more...
- Taylor and Francis 2013; US$ 300.00
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations,... more...
- Taylor and Francis 2013; US$ 159.95
Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of... more...
- Taylor and Francis 2013; US$ 230.00
An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types... more...