EudraLex: B: presentation and content of the dossier

EudraLex: B: presentation and content of the dossier PDF Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages : 0

Get Book Here

Book Description

EudraLex: B: presentation and content of the dossier

EudraLex: B: presentation and content of the dossier PDF Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages : 0

Get Book Here

Book Description


EudraLex: B: presentation and content of the dossier

EudraLex: B: presentation and content of the dossier PDF Author:
Publisher:
ISBN: 9789282843413
Category :
Languages : en
Pages :

Get Book Here

Book Description


The Complete Guide to Medical Writing

The Complete Guide to Medical Writing PDF Author: Mark C. Stuart
Publisher: Pharmaceutical Press
ISBN: 9780853696674
Category : Medical
Languages : en
Pages : 522

Get Book Here

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

Chemical Analysis of Antibiotic Residues in Food PDF Author: Jian Wang
Publisher: John Wiley & Sons
ISBN: 1118067193
Category : Science
Languages : en
Pages : 378

Get Book Here

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

Pharmacovigilance Medical Writing PDF Author: Justina Orleans-Lindsay
Publisher: John Wiley & Sons
ISBN: 1118302060
Category : Medical
Languages : en
Pages : 182

Get Book Here

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

International Pharmaceutical Product Registration PDF Author: Anthony C. Cartwright
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804

Get Book Here

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

Oral Formulation Roadmap from Early Drug Discovery to Development PDF Author: Elizabeth Kwong
Publisher: John Wiley & Sons
ISBN: 1118907876
Category : Medical
Languages : en
Pages : 224

Get Book Here

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

General and Applied Toxicology PDF Author: Bryan Ballantyne
Publisher:
ISBN:
Category : Toxicology
Languages : en
Pages : 784

Get Book Here

Book Description


Phase Appropriate GMP for Biological Processes

Phase Appropriate GMP for Biological Processes PDF Author: Trevor Deeks
Publisher:
ISBN: 9781942911173
Category :
Languages : en
Pages :

Get Book Here

Book Description


Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development PDF Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389

Get Book Here

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.