Guideline For Submitting Samples And Analytical Data For Methods Validation
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Bacteriological Analytical Manual
Author | : United States. Food and Drug Administration. Division of Microbiology |
Publisher | : |
Total Pages | : 180 |
Release | : 1969 |
Genre | : Microbiology |
ISBN | : |
Guideline on General Principles of Process Validation
Author | : |
Publisher | : |
Total Pages | : 32 |
Release | : 1987 |
Genre | : Medical instruments and apparatus industry |
ISBN | : |
The Regulatory Compliance Almanac
Author | : Les Schnoll |
Publisher | : Paton Professional |
Total Pages | : 564 |
Release | : 2008 |
Genre | : Law |
ISBN | : 9781932828191 |
Drug Development
Author | : Charles E. Hamner |
Publisher | : CRC Press |
Total Pages | : 319 |
Release | : 2019-06-12 |
Genre | : Medical |
ISBN | : 0429552998 |
Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Pharmaceutical Dosage Forms
Author | : Kenneth E. Avis |
Publisher | : Routledge |
Total Pages | : 592 |
Release | : 2018-05-04 |
Genre | : Medical |
ISBN | : 1351425188 |
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.
Biosensors
Author | : Jagriti Narang |
Publisher | : CRC Press |
Total Pages | : 132 |
Release | : 2017-09-19 |
Genre | : Medical |
ISBN | : 135164503X |
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.
Generic Drug Development Project Management
Author | : Sandeep Narayan Patil, PMP |
Publisher | : Notion Press |
Total Pages | : 281 |
Release | : 2021-04-17 |
Genre | : Medical |
ISBN | : 1638067554 |
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.