Bücher der Reihe Drugs and the Pharmaceutical Sciences

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease.

A work which furnishes different perspectives on pharmaceutical information automation from industry and system automation professionals - demonstrating how to fulfil computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.

Reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients. This book provides an scientific basis for safety evaluation and risk assessment. It identifies the differences between excipients, food ingredients, and drug products; and more. It is for pharmacists; toxicologists; and others.

A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that meet the standards of regulatory agencies. It reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, and automation in pharmaceutical analysis.

Reviews important colloidal drug delivery systems, that include nanoparticles, liposomes, niosomes, microemulsions and ointments. This book provides over 1000 bibliographic citations, as well as tables, drawings, equations and photographs.

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 international sphere and reviews regulatory processes for drug approvals in the United States and Europe.

Provides information on containment processes. This book reviews the historical context, definition, evolution, and application of containment technology, analyzes a variety of containment techniques in construction, and examines "people protection" vs. "product protection" and the role of source-contamination in each.

Supplying a framework for employing simulation as an experiment, this book discusses how to clinically trial designs according to their probability for success. It gives techniques to define distributions of virtual subjects' characteristics, and methods to determine the sensitivity of the trial design.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Laboratory Auditing for Quality and Regulatory Compliance

Pharmaceutical Photostability and Stabilization Technology

Injectable Dispersed Systems

This book is devoted to the effects of food and of nutrient intake on the disposition of foreign compounds, and discusses effects of drugs on nutrition. It is intended for nutritionists and clinical investigators concerned with interpretation of aberrant effects of therapeutic drugs.

Microencapsulation

Dose Optimization in Drug Development

Generic Drug Product Development

Pharmaceutical Project Management

Collects discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products and bioequivalence. This title considers key elements in the formulation of generic drug products including availability of raw materials and chemical purity.

Pharmaceutical Preformulation and Formulation

Active Pharmaceutical Ingredients