Bücher der Reihe Drugs and the Pharmaceutical Sciences

Pharmaceutical Photostability and Stabilization Technology

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the 'why' and the 'how', emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Generic Drug Product Development

Drug Stereochemistry

Biodrug Delivery Systems

Pharmaceutical Process Engineering

Proteins and Peptides

Active Pharmaceutical Ingredients

Pharmaceutical Preformulation and Formulation

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 Project Management

Generic Drug Product Development

Dose Optimization in Drug Development

Microencapsulation

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.

Injectable Dispersed Systems

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

This book brings together an up-to-date account of instructions in the chemical and biological methods of analysis for antibiotics. It is helpful for all scientific workers in the diversified community of industrial, medical, academic, and governmental antibiotic laboratories.

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.

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.

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.

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.

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 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 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.

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.

Offers coverage of the scientific and pharmaceutical aspects of protein delivery from controlled release microparticulate systems - emphasizing protein stability during encapsulation and release.

This timely resource compares single-photon emission tomography (SPECT), used mainly withTechnetium and iodine for routine clinical examinations, and positron emission tomography(PET) , employing short-lived radionuclides of carbon, oxygen, nitrogen, and fluorine in researchinvestigations

Suitable for researchers and students in pharmacology and related fields, this title explains the techniques for investigating the absorption, distribution, metabolism, and excretion of test compounds using laboratory animals. It describes types of experiments, study design, and animal preparation and maintenance.