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)
Commercial product formulation
Quality control and bioequivalence
Drug product performance
ANDA regulatory process
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.
Brand: CRC Press
Used Book in Good Condition
The authorised South African distributor of this product is under no obligation to honour the manufacture's guarantees/warranties or to provide after-sales service.
Please note that this item is imported from the USA, and is designed to be used in the USA. In addition, if the unit is powered it will come with a US plug and an adapter/transformer may be required. Please click here for more information on power requirements, or check with us if you are unsure or need any assistance!
Please also note that certain items cannot be imported, these include Alcohol, Animals, Batteries, Flammable Materials, Currency, Food, Furs, Chemicals, Explosives, Medications, Plants, Seeds, Supplements, Pressurized Cans, Tactical Equipment, Vitamins, Weaponry and Weaponry Accessories. In these cases, the item and information is displayed for reference purposes only. If you are not sure if we are permitted to bring an item, please send us an e-mail with a link to the item to confirm.
Please also ensure that you are ordering the correct item for your particular application as returns to the USA are costly. Product reviews are also provided for most of our items, which can give you a good idea for possible things to look out for and the quality of the item. By clicking Add to Cart, you are confirming that the item is correct and you accept the conditions listed here.