T�tulo: Contract Research and Development Organizations: Their Role in Global Product Development
Editor: Springer
Fecha de publicaci�n: 2014
Idioma: Ingl�s
ISBN 10: 148999890X
ISBN 13: 9781489998903
Encuadernaci�n: Encuadernaci�n de tapa blanda
Estado: New

Acerca de

Sinopsis

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.

Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Acerca del autor

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, an eighteen year old consulting firm with six employees and more than 450 clients (including 120 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has published 41 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 34 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (92 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 19 years.

Charles ‘Bart’ Spainhour, V.M.D., Ph.D., DABT, DABFS, DABFM received his B.S. from Michigan State University, veterinary degree from the University of Pennsylvania and doctoral degree from Texas A&M University. Dr. Spainhour has over forty-two years experience in the pharmaceutical industry and with various aspects of drug development. Currently, Dr. Spainhour is the Chief Scientific Officer for Calvert Holdings and is also the President and Chief Scientific Officer for Calvert Laboratories, where he works with clients in the design, conduct and management of safety assessment programs. He has played a significant leadership role in the development of Calvert Laboratories into the highly respected CRO that it is today. Previously, he has worked in the areas of pharmacokinetics & metabolism, biochemical pharmacology and process chemistry. His employment history includes MDS Pharma Services, Phoenix International Life Sciences, Chrysalis International, Pharmakon and SmithKline Corporation (presently GSK). Dr. Spainhour has also worked as a veterinarian in private practice and as a forensic toxicologist and independent consultant, founding The Summit Group, which has provided services in the areas of safety pharmacology, toxicology and drug development. Dr. Spainhour is a Diplomate of the American Board of Toxicology, American Board of Forensic Science, American Board of Forensic Medicine and is a memberof numerous scientific and professional organizations, including the American College of Toxicology, Society of Toxicology, Roundtable of Toxicology Consultants, Society of Toxicologic Pathology, Drug Information Association, American Chemical Society and the Regulatory Affairs Professionals Society.

"Sobre este t�tulo" puede pertenecer a otra edici�n de este libro.

Descripci�n de la librer�a

Hello! Ria Christie Collections is an online venture that was initially set up in 2012 to sell books. We do not have a physical high street store. We are professional online booksellers. We only sell brand new books in perfect condition that we source from various suppliers and the publishers. Primarily, our aim is to provide an excellent service to all our customers. We always work as a team to achieve this. Our other objectives are to: 1. Ensure that all our products reach their destination quickly in a safe and secure manner 2. Answer to all our customer queries within 24 hours 3. Ensure that our customers are happy with their purchases 4. Provide all the items at a competitive price 5. Always listen to our customers Ria Christie Collections is not a registered company. It is a Sole Trader venture. Other key information is shown below: Contact Person Name: Rakesh Luchmun (Mr) Storefront Name: Ria Christie Collections Place of Establishment Address: Suite B; ARUN House; ARUN Building Arundel Road Uxbridge UB8 2RR United Kingdom E-Mail Address: riachristie@hotmail.co.uk VAT Number: GB 160 5650 25 We always work hard and aim to comply with all of Abebooks Policies. If you have any issues, please do not hesitate to write to us whether before or after a purchase. We promise to reply to you promptly and, in any case, within 24 hours. Thank you kindly! Yours sincerely Mr Rakesh Luchmun (Founder) and the Ria Christie Collections Team

Ver la p�gina web de la librer�a

Informaci�n empresarial del vendedor

Ryefield Investments Limited
175 Pield Heath Road, Uxbridge, UB8 3NL, United Kingdom

Condiciones de venta y env�o

Condiciones de venta

All Returns and Refund are as per Abebooks policies.

Derecho a cancelaci�n

Si eres un consumidor puedes cancelar el presente contrato de acuerdo con lo indicado a continuaci�n. Son consumidores las personas f�sicas que act�en con un prop�sito ajeno a su actividad comercial, empresarial, oficio o profesi�n.

Documento de informaci�n al consumidor y usuario sobre el desistimiento

Derecho de desistimiento:

Tienes derecho a desistir del presente contrato en un plazo de 14 d�as naturales sin necesidad de justificaci�n.

El plazo de desistimiento expirar� a los 14 d�as naturales del d�a en que t� o un tercero que hayas indicado, distinto del transportista, adquiera la posesi�n material del �ltimo bien, componente o pieza.

Para ejercer el derecho de desistimiento, deber�s notificarnos a Ria Christie Collections, Suite B; (inside) ARUN House; ARUN, Arundel Road; Uxbridge Ind Est, UB8 2RR, Uxbridge, United Kingdom, +44 7727654838, de tu decisi�n de desistir del contrato a trav�s de una declaraci�n inequ�voca (por ejemplo, una carta enviada por correo postal, fax o correo electr�nico). Podr�s utilizar el modelo de formulario de desistimiento que figura a continuaci�n, aunque su uso no es obligatorio. Tienes asimismo la opci�n de cumplimentar y enviar electr�nicamente el modelo de formulario de desistimiento o cualquier otra declaraci�n inequ�voca a trav�s de nuestro sitio web a "Mis pedidos" en "Mi cuenta". Si recurres a esta opci�n, te comunicaremos sin demora en un soporte duradero (por ejemplo, por correo electr�nico) la recepci�n de dicho desistimiento.

Para cumplir el plazo de desistimiento, basta con que la comunicaci�n relativa al ejercicio por tu parte de este derecho sea enviada antes de que venza el plazo correspondiente.

Consecuencias del desistimiento:

En caso de desistimiento por tu parte, te devolveremos todos los pagos recibidos de ti, incluidos los gastos de entrega (con la excepci�n de los gastos adicionales resultantes de la elecci�n por tu parte de una modalidad de entrega diferente a la modalidad menos costosa de entrega ordinaria que ofrezcamos) sin ninguna demora indebida y, en todo caso, a m�s tardar 14 d�as naturales a partir de la fecha en la que se nos informes de tu decisi�n de desistir del presente contrato. Procederemos a efectuar dicho reembolso utilizando el mismo medio de pago empleado por ti para la transacci�n inicial, a no ser que hayas dispuesto expresamente lo contrario; en todo caso, no incurrir�s en ning�n gasto como consecuencia del reembolso.

Podremos retenerte el reembolso hasta haber recibido los bienes, o hasta que hayas presentado una prueba de la devoluci�n de los mismos, seg�n qu� condici�n se cumpla primero. Deber�s devolvernos o entregarnos directamente los bienes a Ria Christie Collections, Suite B; (inside) ARUN House; ARUN Building, Arundel Road; Uxbridge Ind Est, UB8 2RR, Uxbridge, United Kingdom, +44 7727654838, sin ninguna demora indebida y, en cualquier caso, a m�s tardar en el plazo de 14 d�as naturales a partir de la fecha en que nos comuniques tu decisi�n de desistimiento del contrato. Se considerar� cumplido el plazo si efect�as la devoluci�n de los bienes antes de que haya concluido dicho plazo. Deber�s asumir el coste directo de devoluci�n de los bienes. Solo ser�s responsable de la disminuci�n de valor de los bienes resultante de una manipulaci�n distinta a la necesaria para establecer la naturaleza, las caracter�sticas y el funcionamiento de los bienes.

Excepciones al derecho de desistimiento:

La entrega de peri�dicos, publicaciones especializadas o revistas con la excepci�n de contratos de suscripci�n; y
La entrega de contenido digital (incluyendo apps, MP3, etc.) que no hubiera sido entregado en un medio tangible (por ejemplo: CD o DVD), si al realizar tu pedido has aceptado que podemos proceder al env�o del producto y que no resulta posible su cancelaci�n una vez comienza la entrega.

Modelo de formulario de desistimiento

(S�lo debe cumplimentar y enviar el presente formulario si desea desistir del contrato)

A la atenci�n de: (Ria Christie Collections, Suite B; (inside) ARUN House; ARUN, Arundel Road; Uxbridge Ind Est, UB8 2RR, Uxbridge, United Kingdom, +44 7727654838)

Por la presente le comunico/comunicamos* que desisto de mi/desistimos de nuestro* contrato de venta del siguiente bien/prestaci�n del siguiente servicio*

Pedido el/recibido el*:

Nombre del consumidor y usuario o de los consumidores y usuarios:

Domicilio del consumidor y usuario o de los consumidores y usuarios:

Firma del consumidor y usuario o de los consumidores y usuarios (solo si el presente formulario se presenta en papel):

Fecha:

* Eliminar en su caso

Condiciones de env�o

Orders usually ship within 2 business days. If your book order is heavy or oversized, we may contact you to let you know extra shipping is required. Thank you!

Tarifas de env�o de Reino Unido a Estados Unidos de America

Tarifas de env�o de Reino Unido a Estados Unidos de America
Cantidad del pedido	De 6 a 12 d�as h�biles	De 6 a 12 d�as h�biles
Primer art�culo	EUR 13.88	EUR 13.88

Los plazos de entrega los establecen los vendedores y var�an seg�n el transportista y la ubicaci�n. Los pedidos que pasan por la aduana pueden sufrir retrasos y los compradores son responsables de los aranceles o tarifas asociadas. Los vendedores pueden ponerse en contacto con usted en relaci�n con cargos adicionales para cubrir cualquier aumento en los costes de env�o de los art�culos.