Guideline for Submitting Samples and Analytical Data for Methods Validation PDF Download
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Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 34
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 34
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
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Book Description
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
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Book Description
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Les Schnoll
Publisher: Paton Professional
ISBN: 9781932828191
Category : Law
Languages : en
Pages : 564
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Book Description
Author: Charles E. Hamner
Publisher: CRC Press
ISBN: 0429552998
Category : Medical
Languages : en
Pages : 319
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Book Description
Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Author: Kenneth E. Avis
Publisher: Routledge
ISBN: 1351425188
Category : Medical
Languages : en
Pages : 592
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Book Description
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
Author: Jagriti Narang
Publisher: CRC Press
ISBN: 135164503X
Category : Medical
Languages : en
Pages : 132
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Book Description
Nanotechnology is a budding field and has a pivotal role in sensing. Nanomaterials exist in various forms such as nanoparticles, nanoclusters, nanobelts, and nanospheres. These nanomaterials act as sensing interfaces and immobilization surfaces for various biomolecules such as enzymes, DNA, and antigens. Therefore, the preparation and characterization of these nanoparticles play an important role in sensing devices. This handbook has evolved from the authors’ teaching and research experience in the field of nanoparticle biosensing. It encompasses protocols for the synthesis of various forms of metal oxide nanoparticles; study of the various characterizing techniques that help deduce the shape, size, and morphology of these nanoparticles; and applications of these nanoparticles in the field of biosensors. It presents voltammetry techniques such as cyclic, linear wave, wave pulse, and differential pulse voltammetry, throws light on the interactions of nanomaterials and biomolecules, and discusses microfluidic devices, which due to their unique capability of miniaturization fascinate many researchers. It is a practical and user-friendly textbook that introduces the various basic principles and practical information that will help undergraduate and advanced-level students and researchers understand the science behind nanoscale sensing.
Author: John V. Crable
Publisher:
ISBN:
Category : Analytical chemistry
Languages : en
Pages : 818
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Book Description
Author: Sandeep Narayan Patil, PMP
Publisher: Notion Press
ISBN: 1638067554
Category : Medical
Languages : en
Pages : 281
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Book Description
This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
