Generic drug product development: solid oral dosage forms
by Kanfer, Isadore Shargel, Leon
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 includ…
Read More ↓Title Statements
- Full title :Generic drug product development : solid oral dosage forms / [edited by] Leon Shargel, Isadore Kanfer.
Summary
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 dru.
Read More ↓Edition Statements
- Publication Date:2004.
Publication Statements
- Publisher(s):Marcel Dekker
- Place of Publication:New York
- Language:eng
- Publication Date:2004.
The Physical Object
- Description:1 online resource (xi, 381 pages) : : illustrations.
Edition Identifiers
- ISBN:1420030418, 9781420030419
- oclc:ocn276798187
- LC Classification:RS55.2 G455 2005eb
- Dewey Decimal:615.1/9
Table of Contents
Front cover; Preface; Contents; Contributors; 1 Introduction to Generic Drug Product Development; 1. SELECTION OF A GENERIC DRUG PRODUCT FOR MANUFACTURE; 2. LEGISLATIVE AND REGULATORY ISSUES; 3. GENERIC DRUG APPROVAL; 3.1. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book); 4. PATENTS; 4.1. Exclusivity; 5. RESOURCES FOR ANDA SUBMISSIONS; 5.1. Guidance Documents for ANDAs; 5.2. Manual of Policies and Procedures; 5.3. Freedom of Information (FOI); 5.4. Additional Resources Regarding Drug Development; 5.5. Drug Master File; 5.6. United States Pharmacopeia.
5.7. International Conference on Harmonisation6. SUMMARY; REFERENCES; 2 Active Pharmaceutical Ingredients; 1. INTRODUCTION; 2. SOURCES OF ACTIVE PHARMACEUTICAL INGREDIENTS; 3. PATENT RESTRICTIONS AND EXCLUSIVITY GRANTED TO AN NDA SPONSOR; 4. COMPARISON WITH INNOVATOR API; 4.1. Chemical Structure; 4.2. Impurity Profile; 4.3. Physical Form; 5. SPECIFICATIONS; 6. DRUG MASTER FILE (DMF); 7. REGULATORY OVERSIGHT OF API MANUFACTURERS; 8. BACPAC (BULK ACTIVE CHEMICAL, POST APPROVAL CHANGES); 9. TECHNICAL PARTNERSHIP BETWEEN THE API MANUFACTURER AND THE DRUG PRODUCT MANUFACTURER.
10. IDENTIFYING AND QUALIFYING …
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