Picture 1 of 1
Gallery
Picture 1 of 1
The Challenge of CMC Regulatory Compliance for Biopharmaceuti
Β£143.18
RRP Β£179.99
Save Β£36.81 (20% OFF)
From Β£12.74 per month for 12 months with *
Condition:
New
A new, unread, unused book in perfect condition with no missing or damaged pages. See the seller's listing for full details.
2 available
- Buy it nowThe Challenge of CMC Regulatory Compliance for Biopharmaceuti... - 9781461348047
Oops! Looks like we're having trouble connecting to our server.
Refresh your browser window to try again.
Postage:
Β£34.18 International Priority Shipping to United States via eBay's Global Shipping Programme.
Located in: Aldershot, United Kingdom
Import charges:
Free amount confirmed at checkout
Delivery:
Estimated between Thu, 8 May and Thu, 15 May to 43230
Includes international tracking
Returns:
60 days return. Buyer pays for return postage. If you use an eBay delivery label, it will be deducted from your refund amount.
Payments:
*From Β£12.74 per month for 12 months.
Shop with confidence
Seller assumes all responsibility for this listing.
eBay item number:285317158937
Item specifics
- Condition
- Book Title
- The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
- ISBN
- 9781461348047
- Publication Year
- 2012
- Type
- Textbook
- Format
- Paperback
- Language
- English
- Publication Name
- The Challenge of Cmc Regulatory Compliance for Biopharmaceuticals
- Item Height
- 254 mm
- Publisher
- Springer-Verlag New York Inc.
- Subject
- Medicine, Chemistry, Pharmacy, Physics
- Item Weight
- 721 g
- Item Width
- 178 mm
- Number of Pages
- 350 Pages
About this product
Product Information
The greater our knowledge increases, the more our ignorance unfolds. U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
Product Identifiers
Publisher
Springer-Verlag New York Inc.
ISBN-13
9781461348047
eBay Product ID (ePID)
141391729
Product Key Features
Number of Pages
350 Pages
Publication Name
The Challenge of Cmc Regulatory Compliance for Biopharmaceuticals
Language
English
Subject
Medicine, Chemistry, Pharmacy, Physics
Publication Year
2012
Type
Textbook
Format
Paperback
Dimensions
Item Height
254 mm
Item Weight
721 g
Item Width
178 mm
Additional Product Features
Country/Region of Manufacture
United States
Item description from the seller
Seller business information
VAT number: GB 976952259
I provide invoices with VAT separately displayed.
CRN: 06687355
About this seller
BOOKS etc.
99.5% positive Feedbackβ’1.8M items sold
Registered as a business seller
Seller Feedback (575,587)
- w***r (65)- Feedback left by buyer.Past 6 monthsVerified purchaseItem as described and despatched in quick time. Item arrived within 3 days and was well packaged. Item was much cheaper than I found elsewhere online. I had a query about my order and the seller responded on the same day and sorted everything out. Would happily buy from seller again
- r***y (407)- Feedback left by buyer.Past 6 monthsVerified purchaseFirst book went missing/didn't arrive, but Jessica in customer support sorted it out, sending a second copy, it arrived fast and safe, as described, well wrapped, good price and quick customer support. Thank you Jessicaππππ₯°πRunes: a Handbook - 9781783276974 (#314128475728)
- a***l (61)- Feedback left by buyer.Past 6 monthsVerified purchaseFantastic experience with this seller. I had an issue with the clay in my kit being dried out, which is something they couldn't have known about before me opening the box. I sent them a message and they replied quickly and kindly with a resolution, replacing my kit for me. Overall the kit was fantastic value and arrived brand new, in perfect condition bar the clay. Very trustworthy and helpful.
Seller Feedback (575,587)
- w***r (65)- Feedback left by buyer.Past 6 monthsVerified purchaseItem as described and despatched in quick time. Item arrived within 3 days and was well packaged. Item was much cheaper than I found elsewhere online. I had a query about my order and the seller responded on the same day and sorted everything out. Would happily buy from seller again
- r***y (407)- Feedback left by buyer.Past 6 monthsVerified purchaseFirst book went missing/didn't arrive, but Jessica in customer support sorted it out, sending a second copy, it arrived fast and safe, as described, well wrapped, good price and quick customer support. Thank you Jessicaππππ₯°πRunes: a Handbook - 9781783276974 (#314128475728)
- a***l (61)- Feedback left by buyer.Past 6 monthsVerified purchaseFantastic experience with this seller. I had an issue with the clay in my kit being dried out, which is something they couldn't have known about before me opening the box. I sent them a message and they replied quickly and kindly with a resolution, replacing my kit for me. Overall the kit was fantastic value and arrived brand new, in perfect condition bar the clay. Very trustworthy and helpful.