This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for ...
The second edition of this text assembles significant ophthalmic advances and encompasses breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery.
The second edition of this text assembles significant ophthalmic advances and encompasses breakthroughs in gene therapy, ocular microdialysis, vitreou...
Primarily intended for pharmaceutical scientists and graduate students, this collection brings together the fundamentals, process engineering, and pharmaceutical applications of supercritical fluid technologies. The 15 chapters describe the preparation of particulate drug and drug delivery systems a
Primarily intended for pharmaceutical scientists and graduate students, this collection brings together the fundamentals, process engineering, and pha...
This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.
This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of t...
Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials. It offers authoritative chapters by esteemed researchers and consultants in industry on the current and evolving state of clinical supplies operations. Tracking emerging trends and the development of new technologies, this Second Edition helps the CTMP operate effectively in the...
Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical ...
This reference helps those new to the world of pharmaceutical development reduce costs, save time, and attain straightforward guidance through each step of the drug approval process - acquainting readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected officials from agencies around the globe.
This reference helps those new to the world of pharmaceutical development reduce costs, save time, and attain straightforward guidance through each st...
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products,...
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used t...
During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines are factors that often influence which variables will be studied, leaving other important information out of the study. Preformulation in Solid Dosage Form Development covers every topic of critical importance to the preformulation stages of drug development. Serving as a handbook or stand-alone reference, this text equips those in academia and the pharmaceutical industry with both basic and applied principles for the...
During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines...
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes...
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two Intern...
An explanation of pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, and whole body kinetics to drug release from polymer reservoirs and matrices. The book focuses on practical applications of drug delivery from a physical and mechanical perspective, highlighting biological systems.
An explanation of pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions...
