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This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as auditors in organizations that follow FDA, EMA, MHRA, WHO, TGA, PIC/S regulations.

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.

Describes the bases for developing dosage forms for use in animals, highlighting the data necessary to meet regulatory approval. This title demonstrates the successful characterization, control, and registration of fresh veterinary medicines. It is suitable for pharmaceutical, animal, and quality control scientists.

This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval.Demonstrates the successful characterization, control, and registration of new veterinary medicines! Thoroughly rewritten and enlarged to reflect the technical advances that have occurred since the previous edition, Development and Formulation of Veterinary Dosage Forms, Second Editiondiscusses the reasons for dosage form selection explains the latest available technologies examines new drug therapeutics reveals up-to-date techniques and applications for pharmacokinetic data covers the formulation of products derived from biotechnology elucidates recent analytical methods shows how to determine the type of dosage form appropriate for particular species and more!Written by a team of international authorities from North America and Europe and containing over 1100 bibliographic citation, figures, and tables, Development and Formulation of Veterinary Dosage Forms, Second Edition is an essential reference for pharmaceutical, animal, and quality control scientists; research pharmacists and pharmacologists; veterinarians; drug quality assurance and regulatory personnel in government and industry; pathologists; microbiologists; virologists; physiologists; toxicologists; and upper-level undergraduate and graduate students in these disciplines.

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.

Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is an invaluable source for drug discovery and development scientists in the biopharmaceutical industry who frequently navigate the maze of protein and peptide pharmacokinetics, pharmacodynamics, and metabolism. Key features include: issues related to delivery of protein and peptide therapeutics in elderly populations and pharmacogenomicslessons learned on the major marketed areas of proteins and peptides, including interleukins, interferons, growth factors, and peptide hormonesinnovations for protein and peptide delivery such as needle-less deliverystrategies for delivery of these molecules to locations such as the eye and brain generic issues of proteins and peptides

The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive source for all professionals involved with filtration and purification practices and compliance, this text describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and buffer filtration.

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.

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

Describes assays used to discover new glycopeptide antibiotics. This work discusses practical techniques for screening, isolating and analyzing glycopeptide antibiotics, correlating structure-activity relationships with the mode of action. It examines relevant chemical aspects of the carbohydrate components of glycopeptide antibodies.

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

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.

Explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as fresh aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single-unit sustained release, and tablet coating.

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.

A comprehensive treatment of the science, technology, and regulation of rate-controlled administration of therapeutic agents, with coverage of the basic concepts, fundamental principles, biomedical rationales, and potential applications. This revised and updated edition (first in 1982) incorporates

This book provides comprehensive information on pharmaceutical dissolution technology. It serves as an invaluable guide to aid the pharmacy professional in selecting and utilizing the available means in overcoming problems in design and development of better dosage forms.

Analyses construction of experiments, focusing on variables, models and other topics. This book examines the concepts and theoretical issues, methodologies for experiment and measurement, and health applications of emulsions and dispersions - describing formulation problems and identifying carriers for the delivery or targeting of drugs.

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.

Describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process. Comparing the advantages and disadvantages of specific techniques, this book shows how to overcome pharmaceutical, technological, and economic constraints on experiment design.

Examining the modern pharmaceutical compacting techniques used to form tablets out of powders, this book describes the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles.

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.

Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications. This book unlocks the potential of supercritical fluids to the development of improved pharmaceutical products.

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.

Provides an coverage of the development, preparation, and application of topical and transdermal therapeutic systems. This book discusses the bioequivalence of dermatological and transdermal dosage forms. It explores the biochemistry and treatment of skin diseases, the structure and function of the skin, and more.