Thiscomprehensive 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:
Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines
Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable...
Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile pr...
It also examines the detection, characterization, and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability.
It also examines the detection, characterization, and assessment of risks on the solid state properties of advanced discovery and early development ca...
This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer's...
This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all writ...
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical...
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the vol...
Natural products and functional/medical foods are now widely acknowledged as having an effect on the microbiome of the intestine, which in turn influences the outcome of certain disease. This book reviews the impact and effects of natural products and functional/medical foods (nutritional programming) on disease management, specifically focusing on diseases related to 1) Inflammation and Immunity, 2) Cancer, COPD and Cachexia, 3) Allergy and 4) Brain Neuro/Immune. Hippocrates said "let medicine be thy food and food be thy medicine." While most of us are familiar with Hippocrates famous words,...
Natural products and functional/medical foods are now widely acknowledged as having an effect on the microbiome of the intestine, which in turn influe...
The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve...
The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through...
Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg (R)), Brentuximab vedotin (Adcetris (R)), and ado-trastuzumab emtansine (Kadcyla (R)), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011).
Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg (R)), Brentuximab vedotin (Adcetris (R)...
Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field.
Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple di...
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs).
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex...
