Drug Discovery and Evaluation Methods in Clinical Pharmacology 1st edition by Gerhard Vogel, Jochen Maas, Alexander Gebauer ISBN 3540898905 978-3540898900

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ISBN 10: 3540898905 
ISBN 13: 978-3540898900
Author:  Gerhard Vogel, Jochen Maas, Alexander Gebauer 

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined.

As these processes can be divided up stepwise we have designed a book series “Drug Discovery and Evaluation” in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series “Pharmacological Assays” comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays”. Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology”.

Drug Discovery and Evaluation Methods in Clinical Pharmacology 1st Table of contents:

• Introduction to Drug Discovery and Development
  • Overview of the drug discovery process
  • Stages of drug development: Preclinical to clinical phases
  • Regulatory and ethical considerations in drug evaluation
• Basic Principles of Clinical Pharmacology
  • Pharmacokinetics and pharmacodynamics in drug evaluation
  • Mechanisms of drug action and therapeutic targets
  • Drug-receptor interactions and dose-response relationships
• Preclinical Drug Development
  • Screening and selection of drug candidates
  • Animal models and their use in preclinical testing
  • In vitro and in vivo testing of drug efficacy and safety
• Pharmacokinetics in Drug Discovery
  • Absorption, distribution, metabolism, and excretion (ADME)
  • Bioavailability and bioequivalence
  • The role of pharmacokinetics in drug formulation
• Pharmacodynamics and Drug Action
  • Mechanisms of drug action at the cellular level
  • Dose-response curves and therapeutic windows
  • Identifying optimal drug targets and biomarkers
• Toxicology and Safety Evaluation
  • Acute and chronic toxicity testing
  • Genotoxicity and carcinogenicity studies
  • Risk assessment and determining safe dosage ranges
• Clinical Trials Design and Methodology
  • Phases of clinical trials: Phase I, II, III, and IV
  • Randomized controlled trials (RCTs) and study design principles
  • Placebo-controlled, blinded, and open-label studies
  • Statistical methods in clinical trials
• Ethical Issues in Clinical Trials
  • Informed consent and patient safety
  • Ethical considerations in placebo use
  • Regulatory guidelines and ethical standards (e.g., GCP, ICH)
• Phase I Clinical Trials
  • Objectives and methodologies in Phase I trials
  • Single-dose and multiple-dose studies
  • Pharmacokinetic profiling and safety assessments
• Phase II and Phase III Clinical Trials
  • Clinical efficacy studies in Phase II
  • Large-scale clinical trials in Phase III: Comparing drugs in populations
  • Endpoints and outcome measures in clinical evaluation
• Biomarkers and Personalized Medicine
  • Use of biomarkers in drug discovery and clinical trials
  • Genetic and genomic profiling for personalized medicine
  • Companion diagnostics and targeted therapies
• Pharmacogenomics in Drug Evaluation
  • The role of genetics in drug metabolism and response
  • Genomic tools for predicting drug efficacy and toxicity
  • The importance of pharmacogenetic testing in clinical trials
• Regulatory Affairs and Drug Approval Process
  • Regulatory bodies and their roles (FDA, EMA, etc.)
  • Submission of Investigational New Drug (IND) applications
  • New Drug Application (NDA) and approval process
  • Post-marketing surveillance and Phase IV trials
• Market Authorization and Post-Market Evaluation
  • Approaches to market approval and drug pricing
  • Phase IV trials: Long-term safety and efficacy evaluation
  • Adverse drug reaction monitoring and reporting
• Challenges in Drug Development
  • High attrition rates in clinical trials
  • Overcoming the hurdles of drug resistance
  • Addressing unmet medical needs and orphan drugs
• Emerging Technologies in Drug Discovery
  • High-throughput screening and virtual screening
  • Advances in drug delivery systems
  • Biotechnology and biopharmaceuticals
• Case Studies in Drug Discovery and Evaluation
  • Detailed case studies of successful and failed drug developments
  • Lessons learned from clinical trials
  • Regulatory challenges in drug approval
• Future Directions in Clinical Pharmacology
  • The role of artificial intelligence and machine learning in drug discovery
  • Innovations in personalized medicine and patient-tailored therapies
  • Global health challenges and the future of drug development

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