Process development Strategy for Upstream and Downstream process optimisation. Process Flow diagram; Bottleneck identification; Medium and chromato optimisation; Continuous or Batch process rationale; Wave bag implementation; Cell separation approaches; Buffer consumption; Cleaning issues; Pre-formulation at bulk level; Fill and Finish anticipation; Freeze-drying elimination; Quality attributes.
Internal production or Outsourcing; Final Dosage anticipation; Associated devices; Quality progress as a function of clinical trial. Dimensioning Sizing of manufacturing equipment, Water for Injection production, Steam production.
A Comprehensive Guide to Toxicology in Preclinical Drug Development - Google книги
Process validation PQ philosophy; protocol review; Cleaning validation. Manufacturing Technology Transfer Assistance Protocol and acceptance criteria review; Equipment suitability; Batch record review; Report review. Technology licensing assistance Value analysis; Intellectual property assessment; Negotiation. Continuous improvement implementation Target definition; Performance assessment; Project definition and follow-up.
Analytical assays : development and validation Triskel's experts can define analytical assays, review protocols, data and validation reports for assays required for:. Non-Clinical Our areas of expertise in pre-clinical development include:. Strategic advice and elaboration of efficient non-clinical development plans. The product class, proposed indication, mode of action and species-specificity can greatly affect the extent of the required development programme. As there is no pre-defined non-clinical programme for biological molecules, Triskel can assist with the preparation of abridged development plans when there are no relevant species available for a given product.
Study follow-up from protocol to report.
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Triskel's staff has the ability to design various study protocols for pharmacodynamic, pharmacokinetic, safety pharmacology and toxicology studies. We can perform day-to-day follow-up of the study and data analysis, and to ensure that high quality, regulatory compliant reports are issued. He has published over technical and scientific papers and authored and co-authored 7 book chapters.
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- Pharmacology/Toxicology information to submit an IND for an anticance…?
- Epub Pharmaceutical Toxicology In Practice: A Guide For Non Clinical Development 2011;
- DRUG DISCOVERY AND FAILURE OF HAZARD IDENTIFICATION.
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Epub Pharmaceutical Toxicology In Practice: A Guide For Non Clinical Development 2011
View on ScienceDirect. Editors: Ali S.
Hardcover ISBN: Imprint: Academic Press. Published Date: 16th November Page Count: For regional delivery times, please check When will I receive my book? Sorry, this product is currently out of stock. Flexible - Read on multiple operating systems and devices. Easily read eBooks on smart phones, computers, or any eBook readers, including Kindle. When you read an eBook on VitalSource Bookshelf, enjoy such features as: Access online or offline, on mobile or desktop devices Bookmarks, highlights and notes sync across all your devices Smart study tools such as note sharing and subscription, review mode, and Microsoft OneNote integration Search and navigate content across your entire Bookshelf library Interactive notebook and read-aloud functionality Look up additional information online by highlighting a word or phrase.
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Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology.
Dedication List of Contributors Foreword Chapter 1.