Generic drug product development : solid oral dosage forms /
Includes bibliographical references and index
| Main Authors: | , |
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| Format: | |
| Language: | eng |
| Published: |
Boca Raton, FL : CRC Press/Taylor & Francis Group,
c201
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| Subjects: |
| _version_ | 1796751697034346496 |
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| author | Shargel, Leon 1941-, editor Kanfer, Isadore |
| author_facet | Shargel, Leon 1941-, editor Kanfer, Isadore |
| author_sort | Shargel, Leon 1941-, editor |
| collection | OCEAN |
| description | Includes bibliographical references and index |
| first_indexed | 2024-03-05T14:09:28Z |
| format | |
| id | KOHA-OAI-TEST:512987 |
| institution | Universiti Teknologi Malaysia - OCEAN |
| language | eng |
| last_indexed | 2024-03-05T14:09:28Z |
| publishDate | c201 |
| publisher | Boca Raton, FL : CRC Press/Taylor & Francis Group, |
| record_format | dspace |
| spelling | KOHA-OAI-TEST:5129872020-12-19T17:19:02ZGeneric drug product development : solid oral dosage forms / Shargel, Leon 1941-, editor Kanfer, Isadore Boca Raton, FL : CRC Press/Taylor & Francis Group,c2014engIncludes bibliographical references and indexActive pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.FEBEHSLSolid dosage forms Generic drugsURN:ISBN:9781420086355 |
| spellingShingle | Solid dosage forms Generic drugs Shargel, Leon 1941-, editor Kanfer, Isadore Generic drug product development : solid oral dosage forms / |
| title | Generic drug product development : solid oral dosage forms / |
| title_full | Generic drug product development : solid oral dosage forms / |
| title_fullStr | Generic drug product development : solid oral dosage forms / |
| title_full_unstemmed | Generic drug product development : solid oral dosage forms / |
| title_short | Generic drug product development : solid oral dosage forms / |
| title_sort | generic drug product development solid oral dosage forms |
| topic | Solid dosage forms Generic drugs |
| work_keys_str_mv | AT shargelleon1941editor genericdrugproductdevelopmentsolidoraldosageforms AT kanferisadore genericdrugproductdevelopmentsolidoraldosageforms |