Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages : 0
Book Description
EudraLex: B: presentation and content of the dossier
Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages : 0
Book Description
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages : 0
Book Description
EudraLex: B: presentation and content of the dossier
Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages :
Book Description
The Complete Guide to Medical Writing
Author: Mark C. Stuart
Publisher: Pharmaceutical Press
ISBN: 9780853696674
Category : Medical
Languages : en
Pages : 522
Book Description
'The Complete Guide to Medical Writing' is intended to consider all aspects of medical/scientific writing in one concise introductory text. It explains how to get published, how to write for a particular audience or in a particular media, what the publishing processes are and what the financial rewards might be.
Publisher: Pharmaceutical Press
ISBN: 9780853696674
Category : Medical
Languages : en
Pages : 522
Book Description
'The Complete Guide to Medical Writing' is intended to consider all aspects of medical/scientific writing in one concise introductory text. It explains how to get published, how to write for a particular audience or in a particular media, what the publishing processes are and what the financial rewards might be.
Chemical Analysis of Antibiotic Residues in Food
Author: Jian Wang
Publisher: John Wiley & Sons
ISBN: 1118067193
Category : Science
Languages : en
Pages : 378
Book Description
An insightful exploration of the key aspects concerning the chemical analysis of antibiotic residues in food The presence of excess residues from frequent antibiotic use in animals is not only illegal, but can pose serious health risks by contaminating products for human consumption such as meat and milk. Chemical Analysis of Antibiotic Residues in Food is a single-source reference for readers interested in the development of analytical methods for analyzing antibiotic residues in food. It covers themes that include quality assurance and quality control, antibiotic chemical properties, pharmacokinetics, metabolism, distribution, food safety regulations, and chemical analysis. In addition, the material presented includes background information valuable for understanding the choice of marker residue and target animal tissue to use for regulatory analysis. This comprehensive reference: Includes topics on general issues related to screening and confirmatory methods Presents updated information on food safety regulation based on routine screening and confirmatory methods, especially LC-MS Provides general guidance for method development, validation, and estimation of measurement uncertainty Chemical Analysis of Antibiotic Residues in Food is written and organized with a balance between practical use and theory to provide laboratories with a solid and reliable reference on antibiotic residue analysis. Thorough coverage elicits the latest scientific findings to assist the ongoing efforts toward refining analytical methods for producing safe foods of animal origin.
Publisher: John Wiley & Sons
ISBN: 1118067193
Category : Science
Languages : en
Pages : 378
Book Description
An insightful exploration of the key aspects concerning the chemical analysis of antibiotic residues in food The presence of excess residues from frequent antibiotic use in animals is not only illegal, but can pose serious health risks by contaminating products for human consumption such as meat and milk. Chemical Analysis of Antibiotic Residues in Food is a single-source reference for readers interested in the development of analytical methods for analyzing antibiotic residues in food. It covers themes that include quality assurance and quality control, antibiotic chemical properties, pharmacokinetics, metabolism, distribution, food safety regulations, and chemical analysis. In addition, the material presented includes background information valuable for understanding the choice of marker residue and target animal tissue to use for regulatory analysis. This comprehensive reference: Includes topics on general issues related to screening and confirmatory methods Presents updated information on food safety regulation based on routine screening and confirmatory methods, especially LC-MS Provides general guidance for method development, validation, and estimation of measurement uncertainty Chemical Analysis of Antibiotic Residues in Food is written and organized with a balance between practical use and theory to provide laboratories with a solid and reliable reference on antibiotic residue analysis. Thorough coverage elicits the latest scientific findings to assist the ongoing efforts toward refining analytical methods for producing safe foods of animal origin.
Pharmacovigilance Medical Writing
Author: Justina Orleans-Lindsay
Publisher: John Wiley & Sons
ISBN: 1118302060
Category : Medical
Languages : en
Pages : 182
Book Description
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
Publisher: John Wiley & Sons
ISBN: 1118302060
Category : Medical
Languages : en
Pages : 182
Book Description
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
International Pharmaceutical Product Registration
Author: Anthony C. Cartwright
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804
Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804
Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Oral Formulation Roadmap from Early Drug Discovery to Development
Author: Elizabeth Kwong
Publisher: John Wiley & Sons
ISBN: 1118907876
Category : Medical
Languages : en
Pages : 224
Book Description
Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
Publisher: John Wiley & Sons
ISBN: 1118907876
Category : Medical
Languages : en
Pages : 224
Book Description
Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
General and Applied Toxicology
Author: Bryan Ballantyne
Publisher:
ISBN:
Category : Toxicology
Languages : en
Pages : 784
Book Description
Publisher:
ISBN:
Category : Toxicology
Languages : en
Pages : 784
Book Description
Phase Appropriate GMP for Biological Processes
Author: Trevor Deeks
Publisher:
ISBN: 9781942911173
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781942911173
Category :
Languages : en
Pages :
Book Description
Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.