Method Validation in Pharmaceutical Analysis (Hardcover)
Language: English
Published by Wiley-VCH Verlag GmbH, Berlin, 2025
- Hardcover
- New
Seller: Grand Eagle Retail, Bensenville, IL, U.S.A.Grand Eagle Retail
AbeBooks seller since October 12, 2005
Condition: New
£ 153.43
Quantity: 1 available
Add to basketItem description from seller
Hardcover. New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualificationAnalytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical proceduresMethod selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategyImplementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.…
Seller Inventory # 9783527348909
- Title
- Method Validation in Pharmaceutical Analysis (Hardcover)
- Author
- Joachim Ermer
- Publisher
- Wiley-VCH Verlag GmbH, Berlin
- Publication year
- 2025
- Condition
- new
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 3527348905
- ISBN 13
- 9783527348909
- Edition
- 3rd Edition
New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14
Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.
This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance.
Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as:
- Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification
- Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures
- Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy
- Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures
Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.
"Synopsis" may belong to another edition of this title.
About the Author
Joachim Ermer worked for 30 years in the pharmaceutical industry, including analytical development, global responsibilities, Head of Quality Control, and head of QC Lifecycle Management, before he started in December 2020 his consultancy business.
Phil W. Nethercote was the analytical leader for the Global Manufacturing and Supply Division of GSK until he retired in 2016. He has over 30 years of experience in the pharmaceutical industry, the majority of which has been with Glaxo, Glaxo Wellcome and GSK.
"About the title" may belong to another edition of this title.
Grand Eagle Retail
Bensenville, IL, U.S.A.
AbeBooks seller since October 12, 2005
Shipping rates within U.S.A.
| Item | 6 to 14 business days | 6 to 16 business days |
|---|---|---|
| First item | £ 0.00 | £ 0.00 |
Payment methods
Seller's business information
APOLLO ONLINE CORP.
605 Geddes Street
Wilmington, DE U.S.A. 19805
Terms of sale
We guarantee the condition of every book as it¿s described on the Abebooks web sites. If you¿ve changed
your mind about a book that you¿ve ordered, please use the Ask bookseller a question link to contact us
and we¿ll respond within 2 business days.
Books ship from California and Michigan.
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 Grand Eagle Retail, Bensenville, Illinois, U.S.A., 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
Orders usually ship within 2 business days. All books within the US ship free of charge. Delivery is 4-14 business days anywhere in the United States.
Books ship from California and Michigan.
If your book order is heavy or oversized, we may contact you to let you know extra shipping is required.