Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges.

Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

« Synopsis » peut appartenir à une autre édition de cet ouvrage.

À propos de l’auteur

Zoltan K Nagy is a Professor of Chemical Engineering in the Davidson School of Chemical Engineering at Purdue University, USA and holds a research professor position at Loughborough University, UK. His research focuses on pharmaceutical systems engineering, advanced process control, crystallization modeling and control approaches and advanced control of particulate systems. He is an international expert in process intensification and advanced control application in integrated batch and continuous pharmaceutical manufacturing systems. He has received awards in the areas of crystallization and control from IEEE, IFAC, European Federation of Chemical Engineering, Royal Academy of Engineering and the European Research Council and he was the recipient of the AIChE's Excellence in Process Development Research Award (2018) and the Pharmaceutical Discovery Development and Manufacturing (PD2M) Forum Award for Outstanding Contribution to QbD for Drug Substance (2019).

Arwa El Hagrasy is currently Acting Quality Assessment Lead, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, FDA. Arwa has been with FDA for over 6 years and has reviewed a wide variety of drug product applications submitted to the Agency, including those implementing emerging technologies and advanced pharmaceutical manufacturing. Arwa has vast experience in industry and academia, with focus on the implementation of process analytical technology tools and continuous manufacturing in the pharmaceutical industry. Arwa received her B.S. in Pharmaceutical Sciences from Cairo University, Egypt, her Ph.D. in Pharmaceutical Sciences from Duquesne University in Pittsburgh, did a post-doctoral appointment in the Chemical Engineering Department at Purdue University, and held Associate Professor position at Faculty of Pharmacy, Cairo University.

Jim Litster is Professor and Head of the Chemical and Biological Engineering Department at the University of Sheffield, following previous academic appointments at Purdue University (2007-2015) and The University of Queensland (1987-2007). His research area is Particulate Products and Processes focusing on production of particles and particulate delivery forms with well controlled size and morphology from sub-micron to millimeter scale using processes such as wet granulation, crystallization and spherical agglomeration. He is an international leading expert on wet granulation with over 30 years experience in the field. A major portion of his current research is in support of continuous manufacturing of pharmaceutical dosage forms. Jim is a Fellow of the Australian Academy of Technological Sciences and Engineering. He has received several awards internationally for his work, including the Pharmaceutical Discovery, Development and Manufacturing Forum Award from the AIChE in 2015.

« A propos de ce titre » peut appartenir à une autre édition de cet ouvrage.

preigu

Osnabrück, Allemagne

Vendeur avec une évaluation de 5 étoiles

Vendeur AbeBooks depuis 5 août 2024

Frais d'expédition de Allemagne vers Etats-Unis

Article	60 à 60 jours ouvrés	60 à 60 jours ouvrés
Premier article	EUR 70,00	EUR 70,00

Les délais de livraison sont fixés par les vendeurs et varient en fonction du transporteur et du lieu. Les commandes transitant par les douanes peuvent être retardées et les acheteurs sont responsables de tous les droits ou frais associés. Les vendeurs peuvent vous contacter au sujet de frais supplémentaires afin de couvrir toute augmentation des coûts d'expédition de vos articles.

Modes de paiement

Paypal

Description de la boutique

preigu betreibt einen Onlineversandhandel mit über 1 Mio. Produkten in verschiedenen Sortimenten. Das Kernsortiment besteht aus Büchern, Medien und Spielwaren. Ein gelungenes Einkaufserlebnis ist das Ziel einer jeden Bestellung bei preigu, denn der Kunde und seine Zufriedenheit stehen an erster Stelle. preigu setzt daher auf einen kompetenten Kundenservice, funktionierende Prozesse und schnelle Reaktion.

Spécialité

Bücher, Spielwaren

Profil professionnel du vendeur

preigu GmbH & Co. KG

Lengericher Landstraße 19
Osnabrück, Allemagne 49078

Contacter le vendeurConsulter les articles de ce vendeurAfficher la vitrine du vendeur

Conditions de vente

About Us

Legal website operator identification:

preigu GmbH & Co. KG
Lengericher Landstr. 19
49078 Osnabrück
Germany

Telephone: +49 (0) 541 / 580 72 84
Email: mail@preigu.de

VAT No: DE 455 380 498
AG Osnabrück - HRA 209647

PhG: preigu Verwaltung GmbH
AG Osnabrück - HRB 221793
CEO: Ansas Meyer

We are neither willing nor obliged to participate in dispute resolution proceedings before consumer arbitration boards.

We are a member of the initiative "FairCommerce" since 30.11.2016.
For more information, see: https://www.haendlerbund.de/de/haendlerbund/interessenvertretung/faircommerce

Droit de rétractation

Instructions for revocation

Right of withdrawal for the sale of goods

Revocation right for consumers
(A ‘consumer' is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)

Instructions for revocation

Revocation right
You have the right to revoke this contract within 14 days without specifying any reasons.
The revocation period is 14 days with effect from the day,

on which you or a third party nominated by you, which is not the carrier, had taken possession of the products, provided you had ordered one or more products within the scope of a standard order and this/these product/products is/are delivered uniformly;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last product, provided you had ordered several products within the scope of a standard order and these products are delivered separately;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last part delivery or the last unit, provided you had ordered a product, which is delivered in several part deliveries or units;

To exercise your right of withdrawal, you must inform us (preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, Telephone number: +49 (0) 541 / 580 72 84, E-Mail address: mail@preigu.de) by means of a clear declaration (e.g. a letter sent by post, or an e-mail) of your decision to withdraw from this contract. You can use the attached model withdrawal form for this purpose, which is, however, not mandatory.

You can also exercise your right of withdrawal online by clicking on a button labelled accordingly (such as ‘Withdraw from contract' or similar) on the AbeBooks/ZVAB website. If you use this online function, you will immediately receive a confirmation of receipt on a durable medium (e.g. via email) containing information on the content of the withdrawal notice, as well as the date and time of its receipt.

In order to safeguard the revocation period, it is sufficient that you send the notification about the exercise of the revocation right before the expiry of the revocation period.

Consequences of the revocation

If you revoke this contract, we shall repay all the payments, which we received from you, including the delivery costs (with the exception of additional costs, which arise from that fact that you selected a form of delivery other than the most reasonable standard delivery offered by us), immediately and at the latest within 14 days from the day on which we received the notification about the revocation of this contract from you. We use the same means of payment, which you had originally used during the original transaction, for this repayment unless expressly agreed otherwise with you; you will not be charged any fees owing to this repayment.

We can refuse the repayment until the products are returned to us or until you have furnished evidence that you have sent the products back to us, depending on whichever is earlier.

You must return or transfer the products to us immediately and, in any case, at the latest within 14 days with effect from the day on which you inform us of the revocation of this contract. The deadline is maintained if you send the products before the expiry of the 14 day deadline.

You bear the direct costs for returning the products.

You must pay for any depreciation of the products only if this depreciation can be attributed to any handling with you that was not necessary for checking the condition, features and functionality of the products.

Criteria for exclusion or expiry

The revocation right is not available for contracts

for delivery of products, which are not prefabricated and for whose manufacturing an individual selection or stipulation by the consumer is important or which are clearly tailored to the personal requirements of the consumer;
for delivery of products, which can spoil quickly or whose use-by date would be exceeded quickly;
for delivery of alcoholic drinks, whose price was agreed at the time of concluding the contract, which however can be delivered 30 days after the conclusion of the contract at the earliest and whose current value depends on the fluctuations in the market, on which the entrepreneur has no influence;
for delivery of newspapers, periodicals or magazines with the exception of subscription contracts. The revocation right expires prematurely in case of contracts
for delivery of sealed products, which are not suitable for return for reasons of health protection or hygiene if their seal has been removed after the delivery;
for delivery of products if they have been mixed inseparably with other goods after the delivery, owing to their condition;
for delivery of sound or video recording or computer software in a sealed package if the seal has been removed after the delivery.

Specimen - revocation form

(If you wish to revoke the contract, please fill up this form and send it back to us.)

To preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, Email address: mail@preigu.de :
I/we () herewith revoke the contract concluded by me/ us () regarding the purchase of the following products ()/
the provision of the following service ()
Ordered on ()/ received on ()
Name of the consumer(s)
Address of the consumer(s)
Signature of the consumer(s) (only in case of a notification on paper)
Date

(*) Cross out the incorrect option.

Continuous Pharmaceutical Processing

A propos de cet article

Détails bibliographiques

Synopsis

A propos de ce titre