Cantitate/Preț
Produs
Total produse
Vezi coșul
Good Laboratory Practice for Nonclinical Studies de Graham P. Bunn

Good Laboratory Practice for Nonclinical Studies: Drugs and the Pharmaceutical Sciences

Editat de Graham P. Bunn
en Limba Engleză Hardback – 13 dec 2022
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.
• Unique volume covering FDA inspections of GLP facilities
• Provides a detailed interpretation of GLP Regulations
• Presents the latest on electronic data management in GLP
• Describes GLP and computer systems validation
• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (1) 29537 lei  6-8 săpt.
  CRC Press – 9 oct 2024 29537 lei  6-8 săpt.
Hardback (1) 54738 lei  3-5 săpt. +3664 lei  4-10 zile
  CRC Press – 13 dec 2022 54738 lei  3-5 săpt. +3664 lei  4-10 zile

Din seria Drugs and the Pharmaceutical Sciences

  • 9% Cancer Targeting Therapies: Conventional and Advanced Perspectives
    Preț: 57412 lei
  • 9% Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition
    Preț: 149513 lei
  • Pharmaceutical Inhalation Aerosol Technology, Third Edition
    Preț: 49390 lei
  • 9% Gene Delivery Systems: Development and Applications
    Preț: 93494 lei
  • 9% Preclinical Drug Development
    Preț: 128133 lei
  • 5% Project Management for Drug Developers
    Preț: 56976 lei
  • Advanced Aseptic Processing Technology
    Preț: 36145 lei
  • Pharmaceutical Process Scale-Up
    Preț: 36251 lei
  • 18% Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods
    Preț: 154482 lei
  • 12% Pharmaceutical Extrusion Technology
    Preț: 31243 lei
  • The Art and Science of Dermal Formulation Development
    Preț: 43229 lei
  • Handbook of Drug Metabolism, Third Edition
    Preț: 47310 lei
  • 25% Good Design Practices for GMP Pharmaceutical Facilities
    Preț: 102960 lei
  • Biotechnology: the Science, the Products, the Government, the Business
    Preț: 41935 lei
  • 26% Biomarkers in Clinical Drug Development
    Preț: 98934 lei
  • 24% Emerging Drug Delivery and Biomedical Engineering Technologies: Transforming Therapy
    Preț: 73204 lei
  • 18% Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
    Preț: 128755 lei
  • 18% Patient Safety in Developing Countries: Education, Research, Case Studies
    Preț: 113157 lei
  • 15% Molecular Recognition in Pharmacology
    Preț: 50610 lei
  • 26% Environmental Monitoring for Cleanrooms and Controlled Environments
    Preț: 104376 lei
  • 25% Clean-In-Place for Biopharmaceutical Processes
    Preț: 102313 lei
  • 18% Industrial Hygiene in the Pharmaceutical and Consumer Healthcare Industries
    Preț: 78369 lei
  • 22% Biosimilar Drug Product Development
    Preț: 40386 lei
  • 21% The Pharmaceutical Regulatory Process
    Preț: 36146 lei
  • 18% Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
    Preț: 134436 lei
  • 25% Handbook of Pharmaceutical Granulation Technology
    Preț: 123176 lei
  • 25% Pharmaceutical Powder Compaction Technology
    Preț: 99425 lei
  • 25% Modern Pharmaceutics, Volume 2: Applications and Advances, Fifth Edition
    Preț: 99955 lei
  • 18% Pharmacokinetics
    Preț: 128517 lei
  • 15% Proteins and Peptides: Pharmacokinetic, Pharmacodynamic, and Metabolic Outcomes
    Preț: 50828 lei
  • 18% Physical Characterization of Pharmaceutical Solids
    Preț: 90935 lei
  • 25% Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition
    Preț: 111370 lei
  • 15% Pharmaceutical Experimental Design
    Preț: 46923 lei
  • 18% Pharmaceutical Process Engineering
    Preț: 154403 lei
  • 15% Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development
    Preț: 58527 lei
  • 31% RNA-Seq in Drug Discovery and Development
    Preț: 68294 lei
  • 25% Polymorphism in Pharmaceutical Solids
    Preț: 119409 lei
  • 15% The Clinical Research Process in the Pharmaceutical Industry
    Preț: 46103 lei
  • 18% Pharmaceutical Process Validation: An International
    Preț: 158473 lei
  • 18% Filtration and Purification in the Biopharmaceutical Industry, Third Edition
    Preț: 183013 lei
  • 25% New Drug Approval Process
    Preț: 105545 lei
  • 18% Preformulation in Solid Dosage Form Development
    Preț: 134279 lei
  • 18% Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition
    Preț: 127808 lei
  • 18% Automation and Validation of Information in Pharmaceutical Processing
    Preț: 134672 lei

Preț: 54738 lei

Preț vechi: 59497 lei
-8% Nou

Puncte Express: 821
Preț estimativ în valută:
10476€ • 10807$ • 8866£

Carte disponibilă

Livrare economică 11-25 februarie
Livrare express 25-31 ianuarie pentru 4663 lei

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9780367336271
ISBN-10: 0367336278
Pagini: 206
Ilustrații: 9 Tables, black and white; 4 Line drawings, color; 2 Line drawings, black and white; 4 Illustrations, color; 2 Illustrations, black and white
Dimensiuni: 156 x 234 x 19 mm
Greutate: 0.9 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Public țintă

Academic and Professional Practice & Development

Cuprins

Introduction
1. Subpart A - General Provisions
i) Sec. 58.1 Scope
ii) Sec. 58.3 Definitions.
iii) Sec. 58.10 Applicability to studies performed under grants and contracts.
iv) Sec. 58.15 Inspection of a testing facility.
2. Subpart B - Organization and Personnel
i) Sec. 58.29 Personnel.
ii) Sec. 58.31 Testing facility management.
iii) Sec. 58.33 Study director
iv) Sec. 58.35 Quality assurance unit.
3. Subpart C – Facilities
i) Sec. 58.41 General.
ii) Sec. 58.43 Animal care facilities.
iii) Sec. 58.45 Animal supply facilities.
iv) Sec. 58.47 Facilities for handling test and control articles.
v) Sec. 58.49 Laboratory operation areas
vi) Sec. 58.51 Specimen and data storage facilities
4. Subpart D – Equipment
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
i) Sec. 58.81 Standard operating procedures.
ii) Sec. 58.83 Reagents and solutions.
iii) Sec. 58.90 Animal care.
6. Subpart F - Test and Control Articles
i) Sec. 58.107 Test and control article handling.
ii) Sec. 58.113 Mixtures of articles with carriers.
7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
i) Sec. 58.185 Reporting of nonclinical laboratory study results.
ii) Sec. 58.190 Storage and retrieval of records and data.
9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.
ii) Sec. 58.202 Grounds for disqualification.
iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.
iv) Sec. 58.210 Actions upon disqualification.
v) Sec. 58.213 Public disclosure of information regarding disqualification.
vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.
vii) Sec. 58.219 Reinstatement of a disqualified testing facility.
10. Data Integrity: Paper and Electronic 21CFR11

Notă biografică

Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology and other FDA related industries in quality systems, regulatory action (FDA483, Warning Letter, Consent Decree) remediations and training. Before founding GB Consulting LLC, Graham gained extensive good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate compliance quality auditor and also in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide including Aseptic Training Programs, Batch Record Reviews, QA on the Floor and aseptic training support for 503B Compounding Centers. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and author of several book chapters and journal articles. Graham received a BSc in pharmacy from Brighton University, England, and a MSc in quality assurance and regulatory affairs from Temple University, Philadelphia and is a member of the Regulatory Affairs Professional Society (RAPS).

Descriere

This all-encompassing volume addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings