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Biomedical Sciences - Pharmacology & Toxicology | Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (Eds.)

2nd ed. 2013, XXIV, 1404 p. 243 illus. In 2 volumes, not available separately.

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  • A landmark in the continuously changing world of drugs
  • Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process
  • Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Safety aspects have become an outstanding issue in the process of drug discovery and development and there is furthermore a clear tendency of a continuously increasing  importance of safety. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays. Safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails.

Today, this former sequential way of working is replaced by simultaneous generation of data including safety, pharmacodynamic and pharmacokinetic aspects. Sometimes, even a bench-to-bedside and bedside-to-bench approach connecting preclinical and clinical data as early as possible  is  mandatory. This book tries to overcome the separation into toxicology, pharmacokinetics and clinical applications by showing the connectivity between all these disciplines: There is no real safety evaluation possible without combining toxicological, pharmacodynamic and pharmacokinetic data both from a preclinical and from a clinical environment.

Content Level » Research

Keywords » Bioanalytical Assays - Clinical Studies - Safety Assays - Safety Pharmacokinetics - Safety Pharmacology - Safety Toxicology

Related subjects » Pharmacology & Toxicology

Table of contents 

Safety Pharmacokinetics

Absorption / in vitro Tests / Cell Based

Absorption / in vitro Tests / Non Cell Based

Absorption / in vivo Tests (Radiolabeled)

Bioanalytical Assays - RIA/EIA

Bioanalytical Assays / Gas Chromatography (GC)

Bioanalytical Assays / LC-MS/MS

Bioanalytical Assays / Toxicokinetics

Clinical Studies / Typical Designs

Distribution - Across Barriers

Distribution - in vivo - Perfused Organs

Distribution / in vitro Tests / Protein Binding

Distribution / in vivo / Other Methods

Distribution in vivo

Drug-drug Interaction / Enzyme Induction

Drug-drug Interaction / Enzyme Inhibition

In silico ADME Modeling

Metabolism Studies in vitro and in vivo

Pharmacogenomics in DME

Physicochemical Properties

Population Pharmacokinetics

Safety Pharmacokinetics: Introduction

Typical PK/PD Approaches in Preclinical and Clinical Development

 

Safety Pharmacology

Analgesic Activity and Intravenous and Inhalation Anesthetics

Anti-inflammatory and Antiarthrotic Activity

Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic acids, and Mammalian cells

Blood Constituents

Cardiovascular Pharmacology

Central Nervous System

Chronobiology and the Implications for Safety Pharmacology

Cochlear Safety Tests

Drug Safety on Herbal Medical Products

Drug-Addiction and Drug-Dependency

Endocrine Pharmacology

Magnetic Resonance Imaging and Imaging in Pharmaceutical Safety Assessment

Metabolism Pharmacology

Ocular Safety Tests

Oncology Pharmacology

Peripheral Nervous System

Pulmonary Pharmacology

Renal System

Safe Chemicals / REACH

Safety Pharmacology in Biologics, Antibiotics and Monoclonics

Safety Pharmacology: Introduction and Guidelines

Sensory Systems

Skin Pharmacology

Stem Cells in Safety Pharmacology

Study design and statistics

Transgenic Animals

Zebrafish Model

 

Safety Toxicology

Genotoxicity

In silico Methods

In vitro toxicity testing

International Guidelines

OMICS Technologies

Reproductive Toxicology

Safety Toxicology: Introduction

Testing of Medical Devices

Testing of Monoclonal Antibodies

Toxicogenomics

Absorption / in vitro Tests / Non Cell Based

Absorption / in vivo Tests (Radiolabeled)

Bioanalytical Assays - RIA/EIA

Bioanalytical Assays / Gas Chromatography (GC)

Bioanalytical Assays / LC-MS/MS

Bioanalytical Assays / Toxicokinetics

Clinical Studies / Typical Designs

Distribution - Across Barriers

Distribution - in vivo - Perfused Organs

Distribution / in vitro Tests / Protein Binding

Distribution / in vivo / Other Methods

Distribution in vivo

Drug-drug Interaction / Enzyme Induction

Drug-drug Interaction / Enzyme Inhibition

In silico ADME Modeling

Metabolism Studies in vitro and in vivo

Pharmacogenomics in DME

Physicochemical Properties

Population Pharmacokinetics

Safety Pharmacokinetics: Introduction

Typical PK/PD Approaches in Preclinical and Clinical Development

 

Safety Pharmacology

Analgesic Activity and Intravenous and Inhalation Anesthetics

Anti-inflammatory and Antiarthrotic Activity

Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic acids, and Mammalian cells

Blood Constituents

Cardiovascular Pharmacology

Central Nervous System

Chronobiology and the Implications for Safety Pharmacology

Cochlear Safety Tests

Drug Safety on Herbal Medical Products

Drug-Addiction and Drug-Dependency

Endocrine Pharmacology

Magnetic Resonance Imaging and Imaging in Pharmaceutical Safety Assessment

Metabolism Pharmacology

Ocular Safety Tests

Oncology Pharmacology

Peripheral Nervous System

Pulmonary Pharmacology

Renal System

Safe Chemicals / REACH

Safety Pharmacology in Biologics, Antibiotics and Monoclonics

Safety Pharmacology: Introduction and Guidelines

Sensory Systems

Skin Pharmacology

Stem Cells in Safety Pharmacology

Study design and statistics

Transgenic Animals

Zebrafish Model

 

Safety Toxicology

Genotoxicity

In silico Methods

In vitro toxicity testing

International Guidelines

OMICS Technologies

Reproductive Toxicology

Safety Toxicology: Introduction

Testing of Medical Devices

Testing of Monoclonal Antibodies

Toxicogenomics

Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic acids, and Mammalian cells

Blood Constituents

Cardiovascular Pharmacology

Central Nervous System

Chronobiology and the Implications for Safety Pharmacology

Cochlear Safety Tests

Drug Safety on Herbal Medical Products

Drug-Addiction and Drug-Dependency

Endocrine Pharmacology

Magnetic Resonance Imaging and Imaging in Pharmaceutical Safety Assessment

Metabolism Pharmacology

Ocular Safety Tests

Oncology Pharmacology

Peripheral Nervous System

Pulmonary Pharmacology

Renal System

Safe Chemicals / REACH

Safety Pharmacology in Biologics, Antibiotics and Monoclonics

Safety Pharmacology: Introduction and Guidelines

Sensory Systems

Skin Pharmacology

Stem Cells in Safety Pharmacology

Study design and statistics

Transgenic Animals

Zebrafish Model

 

Safety Toxicology

Genotoxicity

In silico Methods

In vitro toxicity testing

International Guidelines

OMICS Technologies

Reproductive Toxicology

Safety Toxicology: Introduction

Testing of Medical Devices

Testing of Monoclonal Antibodies

Toxicogenomics

Distribution rights 

Distribution rights for India: CBS Publishers, New Delhi, India

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