Generic Drug Product Development - Drugs and the Pharmaceutical Sciences
Latest Publications

TOTAL DOCUMENTS

17

(FIVE YEARS 0)

H-INDEX

1

(FIVE YEARS 0)

Published By CRC Press

9781420086355, 9781420086362

Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-4 ◽

2013 ◽

pp. 31-50 ◽

Author(s):

Quanyin Gao ◽

Dilip Sanvordeker

Keyword(s):

Analytical Methods ◽

Dosage Forms ◽

Solid Dosage Forms ◽

Solid Dosage ◽

Methods Development ◽

Analytical Methods Development

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Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-14 ◽

2013 ◽

pp. 305-318

Author(s):

Lorien Armour ◽

Leon Shargel

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Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-16 ◽

2013 ◽

pp. 333-370

Author(s):

Arthur Tsien

Keyword(s):

Drug Development ◽

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Statistical Considerations for Establishing Bioequivalence

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-12 ◽

2013 ◽

pp. 243-264

Author(s):

Charles Bon ◽

Sanford Bolton

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Quality Control and Quality Assurance

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-8 ◽

2013 ◽

pp. 171-182

Author(s):

Loren Gelber

Keyword(s):

Quality Control ◽

Quality Assurance

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Active Pharmaceutical Ingredients

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-3 ◽

2013 ◽

pp. 19-30

Author(s):

Edward Cohen ◽

Steven Sutherland

Keyword(s):

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients

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Drug Product Performance

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-9 ◽

2013 ◽

pp. 183-206

Author(s):

Pradeep Sathe ◽

John Duan ◽

Lawrence Yu

Keyword(s):

Drug Product ◽

Product Performance

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Bioequivalence and Drug Product Assessment

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-11 ◽

2013 ◽

pp. 219-242

Author(s):

Barbara Davit ◽

Dale Conner

Keyword(s):

Drug Product ◽

Product Assessment

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Front Matter

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-1 ◽

2013 ◽

pp. i-xii

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Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-13 ◽

2013 ◽

pp. 265-304

Author(s):

Patrick Noonan

Keyword(s):

Contract Research ◽

Research Organizations

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