Télécharger le livre :  Bioequivalence Requirements in Various Global Jurisdictions

An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory...
Editeur : Springer
Parution : 2025-04-29
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
200,44

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Télécharger le livre :  Peptide Therapeutics

This book explains how peptide-based drug design works, what steps are needed to develop a peptide-based therapeutic, and challenges in synthesis as well as regulatory issues.  It covers the design concept of peptide therapeutics from fundamental principles using...
Editeur : Springer
Parution : 2022-09-26
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
105,49

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Télécharger le livre :  An Introduction to Bioanalysis of Biopharmaceuticals

The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness.The book focuses on a broad...
Editeur : Springer
Parution : 2022-08-23
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
168,79

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Télécharger le livre :  Drug Delivery to the Brain

The development of new CNS drugs is notoriously difficult. Drugs must reach CNS target sites for action and these sites are protected by a number of barriers, the most important being the blood–brain barrier (BBB). Many factors are therefore critical to consider for CNS...
Editeur : Springer
Parution : 2022-05-24
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
179,34

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Télécharger le livre :  Formulating Poorly Water Soluble Drugs

The objective of this third edition is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules. A pharmaceutical scientist’s...
Editeur : Springer
Parution : 2022-05-19
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
231,04

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Télécharger le livre :  Ophthalmic Product Development

This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use.  Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product...
Editeur : Springer
Parution : 2022-02-07
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
168,79

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Télécharger le livre :  Protein Instability at Interfaces During Drug Product Development

Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug...
Editeur : Springer
Parution : 2021-02-12
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
94,94

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Télécharger le livre :  Continuous Pharmaceutical Processing

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research...
Editeur : Springer
Parution : 2020-06-10
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
126,59

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Télécharger le livre :  Mucosal Delivery of Drugs and Biologics in Nanoparticles

Nanotechnology has revolutionized the approach to designing and developing novel drug delivery systems. The last two decades have seen a great interest in the use of nanotechnology to offer efficient ways of delivering new and existing drugs and macromolecules. The...
Editeur : Springer
Parution : 2020-03-18
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
210,99

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Télécharger le livre :  Development of Biopharmaceutical Drug-Device Products

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are...
Editeur : Springer
Parution : 2020-03-13
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
252,14

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Télécharger le livre :  Practical Statistics for Pharmaceutical Analysis

This is an introductory statistics book designed to provide scientists with practical information needed to apply the most common statistical tests to laboratory research data. The book is designed to be practical and applicable, so only minimal information is devoted...
Editeur : Springer
Parution : 2019-12-10
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
89,66

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Télécharger le livre :  Targeted Intracellular Drug Delivery by Receptor Mediated Endocytosis

This book elaborates on drug delivery targeting via intracellular delivery, specifically through the Receptor Mediated Endocytosis (RME) approach, due to the involvement of cellular receptors in various grave diseases. Targeted delivery relies on two basic approaches,...
Editeur : Springer
Parution : 2019-11-09
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
94,94

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Télécharger le livre :  The Role of Microstructure in Topical Drug Product Development

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of...
Editeur : Springer
Parution : 2019-08-07
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
158,24

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Télécharger le livre :  The Science and Regulations of Naturally Derived Complex Drugs

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing;...
Editeur : Springer
Parution : 2019-04-23
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
157,74

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Télécharger le livre :  Biosimilars

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the...
Editeur : Springer
Parution : 2018-12-13
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF
179,34

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Télécharger le livre :  Particles and Nanoparticles in Pharmaceutical Products

This edited volume brings together the expertise of numerous specialists on the topic of particles – their physical, chemical, pharmacological and toxicological characteristics – when they are a component of pharmaceutical products and formulations. The book discusses...
Editeur : Springer
Parution : 2018-09-06
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
116,04

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Télécharger le livre :  Bioequivalence Requirements in Various Global Jurisdictions

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies,...
Editeur : Springer
Parution : 2017-12-05
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
220,49

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Télécharger le livre :  Non-Biological Complex Drugs

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). This book illustrates the challenges associated with NBCD development, as well as the complexity of...
Editeur : Springer
Parution : 2015-06-24
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : PDF, ePub
105,49

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Télécharger le livre :  Quality by Design for Biopharmaceutical Drug Product Development

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD...
Editeur : Springer
Parution : 2015-04-01
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : ePub
220,49

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Télécharger le livre :  Antibody-Drug Conjugates

This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case...
Editeur : Springer
Parution : 2015-03-05
Collection : AAPS Advances in the Pharmaceutical Sciences Series
Format(s) : ePub
105,49

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