Generic Drug Product Development
Home > Mathematics and Science Textbooks > Biology, life sciences > Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)


     0     
5
4
3
2
1



Out of Stock


Notify me when this book is in stock
X
About the Book

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

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

About the Author :
Leon Shargel, PhD is the manager and founder of Applied Biopharmaceutics, LLC, a pharmaceutical consulting firm. Dr. Shargel is also an Affiliate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore. He has wide experience in industry and academia and has more than 200 publications, including several leading textbooks in pharmaceutical education and the generic pharmaceutical industry. Dr. Shargel received his Ph.D. in pharmacology from the George Washington University, Medical Center, Washington, D.C., and his B.S. in pharmacy from the University of Maryland, Baltimore, MD. Isadore Kanfer, PhD is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999-2007), Rhodes University, Grahamstown, South Africa. Dr. Kanfer has been a visiting professor at the University of California-San Francisco and the University of North Carolina School of Pharmacy, Chapel Hill. He spent several years in the pharmaceutical industry in Canada and has written or contributed to several book chapters and more than 200 research publications and conference presentations. Dr. Kanfer received his B.Sc. in pharmacy and Ph.D. in pharmaceutics from Rhodes University, Grahamstown, South Africa.

Review :
"Written by experts from academia, industries, and regulatory agency, this is an update of a comprehensive review of the generic oral solid drug product development process. It presents various aspects of generic drug product development with formulation development through to post-approval changes. This edition includes a new chapter on the U.S. Pharmacopeial Convention and its role in harmonization. ... This book will be a standard reference for everyone working on or studying generic drug product development, in industry, academia, and regulatory agency." —Rahmat M. Talukder, PhD, RPh, West Coast University School of Pharmacy, in Doody's Book Reviews "This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development." —Emma McConnell, Medical Writer


Best Sellers


Product Details
  • ISBN-13: 9781040170816
  • Publisher: Taylor & Francis Ltd
  • Publisher Imprint: CRC Press
  • Language: English
  • Sub Title: Solid Oral Dosage Forms, Second Edition
  • ISBN-10: 1040170811
  • Publisher Date: 24 Oct 2013
  • Binding: Digital (delivered electronically)
  • Series Title: Drugs and the Pharmaceutical Sciences


Similar Products

Add Photo
Add Photo

Customer Reviews

REVIEWS      0     
Click Here To Be The First to Review this Product
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)
Taylor & Francis Ltd -
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)
Writing guidlines
We want to publish your review, so please:
  • keep your review on the product. Review's that defame author's character will be rejected.
  • Keep your review focused on the product.
  • Avoid writing about customer service. contact us instead if you have issue requiring immediate attention.
  • Refrain from mentioning competitors or the specific price you paid for the product.
  • Do not include any personally identifiable information, such as full names.

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition(Drugs and the Pharmaceutical Sciences)

Required fields are marked with *

Review Title*
Review
    Add Photo Add up to 6 photos
    Would you recommend this product to a friend?
    Tag this Book Read more
    Does your review contain spoilers?
    What type of reader best describes you?
    I agree to the terms & conditions
    You may receive emails regarding this submission. Any emails will include the ability to opt-out of future communications.

    CUSTOMER RATINGS AND REVIEWS AND QUESTIONS AND ANSWERS TERMS OF USE

    These Terms of Use govern your conduct associated with the Customer Ratings and Reviews and/or Questions and Answers service offered by Bookswagon (the "CRR Service").


    By submitting any content to Bookswagon, you guarantee that:
    • You are the sole author and owner of the intellectual property rights in the content;
    • All "moral rights" that you may have in such content have been voluntarily waived by you;
    • All content that you post is accurate;
    • You are at least 13 years old;
    • Use of the content you supply does not violate these Terms of Use and will not cause injury to any person or entity.
    You further agree that you may not submit any content:
    • That is known by you to be false, inaccurate or misleading;
    • That infringes any third party's copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy;
    • That violates any law, statute, ordinance or regulation (including, but not limited to, those governing, consumer protection, unfair competition, anti-discrimination or false advertising);
    • That is, or may reasonably be considered to be, defamatory, libelous, hateful, racially or religiously biased or offensive, unlawfully threatening or unlawfully harassing to any individual, partnership or corporation;
    • For which you were compensated or granted any consideration by any unapproved third party;
    • That includes any information that references other websites, addresses, email addresses, contact information or phone numbers;
    • That contains any computer viruses, worms or other potentially damaging computer programs or files.
    You agree to indemnify and hold Bookswagon (and its officers, directors, agents, subsidiaries, joint ventures, employees and third-party service providers, including but not limited to Bazaarvoice, Inc.), harmless from all claims, demands, and damages (actual and consequential) of every kind and nature, known and unknown including reasonable attorneys' fees, arising out of a breach of your representations and warranties set forth above, or your violation of any law or the rights of a third party.


    For any content that you submit, you grant Bookswagon a perpetual, irrevocable, royalty-free, transferable right and license to use, copy, modify, delete in its entirety, adapt, publish, translate, create derivative works from and/or sell, transfer, and/or distribute such content and/or incorporate such content into any form, medium or technology throughout the world without compensation to you. Additionally,  Bookswagon may transfer or share any personal information that you submit with its third-party service providers, including but not limited to Bazaarvoice, Inc. in accordance with  Privacy Policy


    All content that you submit may be used at Bookswagon's sole discretion. Bookswagon reserves the right to change, condense, withhold publication, remove or delete any content on Bookswagon's website that Bookswagon deems, in its sole discretion, to violate the content guidelines or any other provision of these Terms of Use.  Bookswagon does not guarantee that you will have any recourse through Bookswagon to edit or delete any content you have submitted. Ratings and written comments are generally posted within two to four business days. However, Bookswagon reserves the right to remove or to refuse to post any submission to the extent authorized by law. You acknowledge that you, not Bookswagon, are responsible for the contents of your submission. None of the content that you submit shall be subject to any obligation of confidence on the part of Bookswagon, its agents, subsidiaries, affiliates, partners or third party service providers (including but not limited to Bazaarvoice, Inc.)and their respective directors, officers and employees.

    Accept

    Fresh on the Shelf


    Inspired by your browsing history


    Your review has been submitted!

    You've already reviewed this product!