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(Ebook PDF) Generic Drug Development Solid Oral Dosage Forms Drugs and the Pharmaceutical Sciences 1st Edition by Leon Shargel 0824754603 9780824754600 Full chapter

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Generic Drug Development Solid Oral Dosage Forms Drugs and the Pharmaceutical Sciences 1st Edition Leon Shargel Digital Instant Download

Author(s): Leon Shargel
ISBN(s): 9780824754600, 0824754603
Edition: 1
File Details: PDF, 3.13 MB
Year: 2004
Language: english
SKU: EB-2411960 Category: Tag:

Generic Drug Development Solid Oral Dosage Forms Drugs and the Pharmaceutical Sciences 1st Edition by Leon Shargel – Ebook PDF Instant Download/Delivery: 0824754603, 978-0824754600
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Product details:

ISBN 10:         0824754603
ISBN 13: 978-0824754600
Author:      Leon Shargel    

Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
 

Generic Drug Development Solid Oral Dosage Forms Drugs and the Pharmaceutical Sciences 1st Table of contents:

  1. Generic Drug Product Development and Therapeutic Equivalence
  2. Active Pharmaceutical Ingredients
  3. Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms
  4. Experimental Formulation Development
  5. Scale-up, Technology Transfer, and Process Performance Qualification
  6. Drug Stability
  7. Quality Control and Quality Assurance
  8. Drug Product Performance: In Vitro
  9. ANDA Regulatory Approval Process
  10. Bioequivalence and Drug Product Assessment: In Vivo
  11. Statistical Considerations for Establishing Bioequivalence
  12. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations
  13. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences
  14. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization
  15. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing
  16. Index

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