Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers
Language: English
Published by Academic Press, 2022
- Softcover
- New
Seller: Books Puddle, New York, NY, U.S.A.Books Puddle
AbeBooks seller since November 22, 2018
Condition: New
£ 161.09
Quantity: 3 available
Add to basketItem description from seller
1st edition NO-PA16APR2015-KAP.
Seller Inventory # 26389420323
- Title
- Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers
- Author
- Bittner, Beate; Schmidt, Johannes
- Publisher
- Academic Press
- Publication year
- 2022
- Condition
- New
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 0128237414
- ISBN 13
- 9780128237410
Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients.
Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.
- Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics
- Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies
- Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts
- Discusses how to realize home- and self-administration of biotherapeutics in cancer care
- Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities
"Synopsis" may belong to another edition of this title.
About the Author
Dr. Johannes Schmidt (Global Head Product Optimization, F. Hoffmann―La Roche) is a Chemist, and holds a PhD in Organic Chemistry and Diploma in Pharmaceutical Medicine Development. He has work experience as a Laboratory Head (Analytics), Technical Development Leader, Early Research and Development Project Leader, Clinical Team Leader, and Lifecycle Leader in leading both small molecule and biotherapeutic programs in all phases of drug development and commercialization across multiple therapeutic areas, in guiding establishment of customer-centric target product profiles and implementation of innovative development strategies to maximize patient access; and in guiding strategic initiatives and multifunctional project teams related to formulation and device lifecycle management. His major focus was on maximizing product differentiation and patient access to medicines.
"About the title" may belong to another edition of this title.
Books Puddle
New York, NY, U.S.A.
AbeBooks seller since November 22, 2018
Shipping rates within U.S.A.
| Item | 12 to 19 business days | 12 to 14 business days |
|---|---|---|
| First item | £ 2.95 | £ 5.17 |
Payment methods
Store description
I mainly carry imported books from South East Asia / South Asia for readers of all Age Groups.
Specialty
South Asian and South East Asian Culture, Religion, Art etcSeller's business information
PLETOS INC
6931 51st Avenue, WOODSIDE
Woodside, NY U.S.A. 11377
Terms of sale
We accept return for those books which are received damamged. Though we take appropriate care in packaing to avoid such situation.
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 Books Puddle, New York, New York, 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.