Drug Discovery and Development Volume 2 1st Edition by Mukund Chorghade ISBN 0471398462 9780471398462

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Product details:
ISBN 10: 0471398462
ISBN 13: 9780471398462
Author: Mukund Chorghade
This two-volume set provides a full account of the entire sequence of drug development, from conceptualizing the drug, creating a library of candidates, and conducting clinical trials, to optimizing the synthetic route, marketing the drug, and developing delivery methods. Comprehensive in scope, the set bridges the gap between medicinal and process chemistry.
Discussion includes the discovery of agents for the treatment and management of bacterial infections, Parkinson’s disease, psoriasis, ulcers and stomach pain, atopic dermatitis, asthma, and cancer. Case studies examine the discovery of erythromycin analogs (antibiotics), Tagamet, and Ultiva (remifentanil). Full chapters are devoted to combinatorial chemistry, molecular biology-based drug discovery, genomics, and chemogenomics. Industrial chemists, biologists, biochemists, and business people in the pharmaceutical industry will all benefit from this authoritative reference.

The first volume of this set thoroughly describes conceptualizing a drug, creating a library of candidates for testing, screening those candidates for in vitro and in vivo activity, conducting and analyzing the results of clinical trials, and revising the drug as necessary.

The second volume describes optimizing the synthetic route; manufacturing, outsourcing, and marketing the drug, including coloring; and developing delivery methods.

Drug Discovery and Development Volume 2 1st Edition Table of contents:

• Chapter 1: Advanced Drug Discovery Technologies

  • Innovations in high-throughput screening and its applications.
  • Structure-based drug design (SBDD) and computational approaches.
  • Role of bioinformatics and cheminformatics in drug discovery.
  • New platforms in drug discovery (e.g., artificial intelligence, machine learning).

• Chapter 2: Target Identification and Validation

  • Understanding biological targets and their role in disease pathways.
  • Methods for target identification: genomics, proteomics, and systems biology.
  • Validation techniques: in vitro, in vivo, and animal models.
  • Biomarkers and their role in target validation.

• Chapter 3: Lead Discovery and Optimization

  • Lead generation techniques: virtual screening, fragment-based drug design.
  • Hit-to-lead process: identifying lead compounds and optimizing potency.
  • Structure-activity relationship (SAR) and its importance in optimizing leads.
  • Early-stage optimization for drug-like properties.

• Chapter 4: Preclinical Drug Development

  • In vitro testing: cell culture, receptor binding assays, and enzyme inhibition.
  • In vivo testing: animal models, pharmacodynamics, and pharmacokinetics.
  • Safety and toxicity testing: acute, chronic, and carcinogenicity studies.
  • Regulatory considerations in preclinical development.

• Chapter 5: Drug Formulation and Delivery Systems

  • Challenges in drug formulation: solubility, stability, and bioavailability.
  • Advanced drug delivery systems: nanoparticles, liposomes, and sustained release.
  • Targeted drug delivery technologies for precision medicine.
  • Innovations in injectable, oral, and transdermal drug delivery methods.

• Chapter 6: Clinical Trials – Phases I to III

  • Overview of the clinical trial process.
  • Phase I: Safety, tolerability, and pharmacokinetics in healthy volunteers.
  • Phase II: Efficacy and dose-ranging studies in patients.
  • Phase III: Large-scale trials for efficacy, safety, and regulatory submission.

• Chapter 7: Regulatory Affairs and Drug Approval

  • Overview of regulatory agencies: FDA, EMA, and other global organizations.
  • Regulatory requirements for clinical trials and new drug applications.
  • Drug approval process and the role of Good Manufacturing Practices (GMP).
  • Post-marketing surveillance and pharmacovigilance.

• Chapter 8: Drug Repurposing and New Indications

  • Concept of drug repurposing: using existing drugs for new indications.
  • Case studies of successful drug repurposing.
  • High-throughput screening for off-label uses.
  • Regulatory and safety considerations in drug repurposing.

• Chapter 9: Emerging Therapeutic Areas and Drug Development

  • Advances in biologics and monoclonal antibodies.
  • Immunotherapies and cancer drug development.
  • Gene therapy and personalized medicine.
  • Emerging infectious diseases and the development of antivirals and vaccines.

• Chapter 10: Challenges in Drug Discovery and Development

  • High failure rates and the causes of attrition in drug development.
  • Addressing the complexity of diseases: multi-target approaches.
  • Overcoming drug resistance and developing next-generation therapies.
  • Cost and time challenges in the drug development process.

• Chapter 11: The Future of Drug Discovery

  • Trends in precision medicine and targeted therapies.
  • The role of artificial intelligence and big data in drug development.
  • The rise of gene editing technologies (CRISPR/Cas9) in drug discovery.
  • Collaborative models between academia, industry, and regulatory bodies.

• Chapter 12: Case Studies in Drug Discovery and Development

  • Success stories in drug discovery: Case studies from the pharmaceutical industry.
  • Lessons from failures and understanding where drugs fall short.
  • Analysis of the development process of major drugs in current clinical use.
  • Impact of collaborative research and international partnerships.

• Conclusion

  • Summary of key points discussed in Volume 2.
  • The evolving nature of drug discovery and development.
  • Future challenges and innovations in the field.

• Glossary

  • Definitions of key terms and concepts discussed throughout the book.

• References

  • A comprehensive list of academic references, research papers, and key texts.

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