Integrated pharmaceutics : applied preformulation, product design, and regulatory science / Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner.
By: Al-Achi, Antoine
Contributor(s): Gupta, Mali Ram | Stagner, William CraigCall number: QV744 A316I 2013 Material type: BookPublisher: Hoboken, N.J. : John Wiley & Sons, c2013. Description: xix, 991 p. : ill., charts.ISBN: 9780470596920 (hbk.).Subject(s): Chemistry, Pharmaceutical | Biopharmaceutics | Dosage forms -- Standards | Drug design | Drug and narcotic control
Mathematical concepts -- Thermodynamics -- Solubility and dissolution -- Biological aspects of formulations -- Interfacial properties -- Adsorption phenomenon -- Rheological principles -- Chemical stability and shelf-life determination -- Particle science -- Basic statistics and design of experimental concepts -- Formulation development concepts -- The product design process -- Tablet product design -- Capsule product design -- Dispersed system product design -- Aerosol product design -- Sterile injectable product design -- Ophthalmic product design -- Transdermal product design -- Oral modified-release product design -- Regulatory practices and guidelines -- Regulations for compounding pharmacies -- IND and NDA phase-appropriate new drug development process -- Generics, biosimilars, and OTCs -- Accelerated new drug approval and expedited access of new therapies -- Post-drug approval activities -- Drug master files and EU dossiers -- Commissioning and qualification -- Quality systems and controls -- Safety, toxicology, and pharmacogenomics -- Regulatory science initiatives for advancing public health.