Pharmaceutical Drug Development and Regulations Reference from C.H.I.P.S.

New Drug
Approval Process

Global Challenges and Solutions
Fifth edition
edited by Richard A. Guarino

The thoroughly revised Fifth edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

  • advances in international regulatory requirements, including ICH guidelines and harmonization
  • a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
  • the latest regulatory requirements for expediting new drug approvals
  • strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
  • and more


Part I: Administartive Guidelines for New Product Development

  1. Drug Development Teams
  2. FDA Approvable Indications and Other Considerations
  3. Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format
  4. Technology Change—Enabling Clinical Research and Drug Development Processesk
  5. Working with a Contract Research Organization (CRO)
  6. Industry and FDA Liaison

Part II: Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval

  1. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
  2. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator’s Brochure (IB)
  3. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
  4. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
  5. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
  6. The Biologic License Application
  7. Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
  8. New Medical Device Approval Process in the United States
  9. Orphan Drugs

Part III: Developing Clinical Research Trials

  1. Clinical Research Protocols
  2. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
  3. HIPAA: A New Requirement to the Clinical Study Process
  4. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting
  5. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions

Part IV: Global Regulations for Good Clinical Practices (GCP)

  1. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
  2. Quality Assurance
  3. Managing and Monitoring Clinical Trials
  4. European CT Directive: Implementation and Update

Part V: Specific Areas of New Product Submissions

  1. Combination Products
  2. The Current State of GXP in China

Acronyms and Initialisms

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New Drug Approval Process:
Global Challenges and Solutions

Fifth edition
edited by Richard A. Guarino

2009 • 574 pages • $248.95 + shipping
Texas residents please add 6.75 % sales tax

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