Generic Drug Product Development : Solid Oral Dosage Forms
Shargel, Leon (EDT); Kanfer, Isadore (EDT)
Language: English
Published by CRC Press, 2013
Series: Book 37 of 80 - Drugs and the Pharmaceutical Sciences
- Hardcover
- Used
Seller: GreatBookPricesUK, Woodford Green, United KingdomGreatBookPricesUK
AbeBooks seller since January 28, 2020
Condition: Used - As new
£ 238.92
Quantity: Over 20 available
Add to basketItem description from seller
Unread book in perfect condition.
Seller Inventory # 6751885
- Title
- Generic Drug Product Development : Solid Oral Dosage Forms
- Author
- Shargel, Leon (EDT); Kanfer, Isadore (EDT)
- Publisher
- CRC Press
- Publication year
- 2013
- Condition
- As New
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 1420086359
- ISBN 13
- 9781420086355
- Edition
- 2nd Edition
- Series
- Book 37 of 80: Drugs and the Pharmaceutical Sciences
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 Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products―from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.
Major topics discussed include:
- Active pharmaceutical ingredients
- Experimental formulation development, including a new section on Quality by Design (QbD)
- Scale-up
- Commercial product formulation
- Quality control and bioequivalence
- Drug product performance
- ANDA regulatory process
- Post-approval changes
- Post-marketing surveillance
- Legislative and patent challenges
This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
"Synopsis" may belong to another edition of this title.
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.
"About the title" may belong to another edition of this title.
GreatBookPricesUK
Woodford Green, United Kingdom
AbeBooks seller since January 28, 2020
Shipping rates from United Kingdom to U.S.A.
| Item | 10 to 27 business days | 10 to 30 business days |
|---|---|---|
| First item | £ 15.00 | £ 15.00 |
Payment methods
Store description
GreatBookPrices.com is your top source for finding new books at the absolute lowest prices, guaranteed ! We offer big discounts - everyday - on millions of titles in virtually any category, from Architecture to Zoology -- and everything in between. Discover great deals and super-savings, on professional books, text book titles, the newest computer guides, or your favorite fiction authors. You'll find it all - at HUGE SAVINGS - at GreatBookPrices. Browse through our complete online product catalog today. Serving customers around the world for years, we help thousands find just the books they're looking for -- at incredibly low, bargain prices.…
Specialty
TradeBooksSeller's business information
Far Corner Europe Limited
19-20 Bourne Court, 19-20 Bourne Court
Woodford Green, United Kingdom IG8 8HD
Terms of sale
Company Name: GreatBookPricesUK
Legal Entity: Far Corner Europe Limited
Address: 19-20 Bourne Court, Southend Road, Woodford Green Essex, UK IG8 8HD
Registration #: 10691061, VAT GB307932304
Authorized representative: Danielle Hainsey
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to GreatBookPricesUK, Castle Donington, Derby, United Kingdom, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Our warehouses across the globe are fully operational without substantial delays. We are working hard and continue to overcome the daily challenges presented by COVID-19. There have been reports that delivery carriers are experiencing large delays resulting in longer than normal deliveries to customers. We would like to apologize in advance if your item arrives later than the expected delivery due date.
Internal processing of your order will take about 1-2 business days. Please allow an additional 4-14 business days for Royal Mail delivery.