Approved: The Life Cycle of Drug Development
Language: English
Published by Springer, 2025
- Hardcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 223.27
Quantity: 1 available
Add to basketItem description from seller
Druck auf Anfrage Neuware - Printed after ordering - Drug development stands at a transformative threshold in modern medicine. Over the past three decades, biotherapeutics have redefined medical innovation, paving the way for treatments that are not only effective but also accessible. This book provides a comprehensive exploration of the intricate world of drug development, shedding light on the essential balance between efficiency, regulatory compliance, and quality to achieve both innovation and affordability.Written by leading experts, this guide delves into the multi-faceted process of drug development, covering critical areas such as pharmacology, biomarkers, toxicology, product development, manufacturing, and clinical trials-all framed within the stringent requirements set by the FDA. Readers will find in-depth discussions on the latest technologies, statistical approaches, and quality assurance measures essential to navigating today's complex regulatory landscape.With practical case studies, project reports, and curated article reviews, this book offers valuable insights into risk assessment and mitigation at every stage of development. It serves as an indispensable resource for students, educators, and industry professionals, aiming to foster a deeper understanding of the challenges and opportunities in drug development and to inspire the next generation of scientific innovators.…
Seller Inventory # 9783031817861
- Title
- Approved: The Life Cycle of Drug Development
- Author
- Vihang Vivek Ghalsasi
- Publisher
- Springer
- Publication year
- 2025
- Condition
- Neu
- Binding
- Buch
- Language
- English
- ISBN 10
- 3031817869
- ISBN 13
- 9783031817861
- Item weight
- 1,142 grams
- Dimensions
- 241x160x41 mm
Drug development stands at a transformative threshold in modern medicine. Over the past three decades, biotherapeutics have redefined medical innovation, paving the way for treatments that are not only effective but also accessible. This book provides a comprehensive exploration of the intricate world of drug development, shedding light on the essential balance between efficiency, regulatory compliance, and quality to achieve both innovation and affordability.
Written by leading experts, this guide delves into the multi-faceted process of drug development, covering critical areas such as pharmacology, biomarkers, toxicology, product development, manufacturing, and clinical trials―all framed within the stringent requirements set by the FDA. Readers will find in-depth discussions on the latest technologies, statistical approaches, and quality assurance measures essential to navigating today’s complex regulatory landscape.
With practical case studies, project reports, and curated article reviews, this book offers valuable insights into risk assessment and mitigation at every stage of development. It serves as an indispensable resource for students, educators, and industry professionals, aiming to foster a deeper understanding of the challenges and opportunities in drug development and to inspire the next generation of scientific innovators.
"Synopsis" may belong to another edition of this title.
About the Author
Dr. Narendra Chirmule has over three decades of experience in drug development. He has held senior leadership positions at Biocon (Bangalore, India), Amgen (Thousand Oaks, CA) and Merck (Philadelphia, PA) . He is an expert in the area of immune responses to biologics and vaccines. Dr. Chirmule has a Ph.D. from University of Mumbai, post-doctoral training at Cornell University Medical College, New York, and teaching and research experience University of Pennsylvania.
Dr. Vihang Vivek Ghalsasi is a molecular biologist and science educator. With over nine years of industry and academic experience, including roles at Syngene International (Bangalore, India) and Shoolini University (Solan, Himachal Pradesh, India), he is also a BELS-certified copy-editor who supports researchers in scientific writing. Dr. Ghalsasi holds a PhD in molecular biology from Heidelberg University, Germany, and master’s in biotechnology from Indian Institute of Technology Bombay. He is a passionate explorer, travel blogger, and science communicator.
"About the title" may belong to another edition of this title.
Shipping rates from Germany to U.S.A.
| Item | 7 to 10 business days | 5 to 7 business days |
|---|---|---|
| First item | £ 36.06 | £ 49.23 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Store description
Das Unternehmen AHA-BUCH GmbH: Seit der Gründung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisgünstig wie möglich ihren Bücherwunsch zu erfüllen. Unsere Firma beschäftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine Wünsche! Auf über 3700 m2 Fläche haben wir über 100.000 Bücher, Modernes Antiquariat und Spiele auf Lager.
Specialty
Kinderbücher & Kinderhör Casetten, German Books, Software, Natur & Tiere, Ratgeber, Sachbücher, Englische Bücher, Medizin & Gesundheit, Universität & StudiumSeller's business information
AHA-BUCH GmbH
Garlebsen 48
Einbeck, Germany 37574
Terms of sale
Imprint
Seller Info:
AHA-BUCH GmbH
represented by the managing director Christel Glass
Garlebsen 48
37574 Einbeck
Deutschland
Telefon: 055639996039
Telefax: 055639995974
E-Mail: abebooks@aha-buch.de
USt-IdNr.: DE261904229
registered at Commercial register Amtsgerichtes Göttingen
Handelsregisternummer HRB 200691
Alternative dispute resolution:
The European Commission provides a platform for out-of-court online dispute resolution (ODR platform), which can be accessed under https://ec.europa.eu/odr.
We have been a member of the "FairCommerce" initiative since 25.05.2018.
For more information, see www.fair-commerce.de.
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 AHA-BUCH GmbH, Einbeck, Germany, 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
We ship your order after we received them
for articles on hand latest 24 hours,
for articles with overnight supply latest 48 hours.
In case we need to order an article from our supplier our dispatch time depends on the reception date of the articles, but the articles will be shipped on the same day.
Our goal is to send the ordered articles in the fastest, but also most efficient and secure way to our customers.