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Good Clinical Practices in Pharmaceuticals

ISBN: 9781032524078
ISBN: 9781032524078
Εκδόσεις:
Διαστάσεις 24 × 16 cm
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Original price was: 127,00€.Η τρέχουσα τιμή είναι: 119,00€.(Περιλαμβάνεται ΦΠΑ 6%)

Διαθέσιμο - Προπαραγγελία|Διαθεσιμότητα: 23-28 ημέρες

Περιγραφή

Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.

  1. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.
  2. Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice.
  3. Discusses applicable laws and regulations supporting GCP compliance, quality and operations.
  4. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.

Περιεχόμενα

Chapter 1 FDA Submission Requirements
Shanthi Ganeshan and Connie Freund

Chapter 2 Principles of Good Clinical Practice (GCP)
John S. Klein and Sonya T. Edgerton

Chapter 3 Quality by Design, Critical to Quality Factors – ICH E8(R1)
Sandra “Sam” Sather and Jennifer Lawyer

Chapter 4 Good Clinical Practice – Modernizing ICH E6
John S. Klein, Sonya T. Edgerton, and Sandra “Sam” Sather

Chapter 5 Good Clinical Safety Practice
Karen Truhe

Chapter 6 Informed Consent
Joseph Near

Chapter 7 Financial Disclosure by Clinical Investigators
Glenda Guest

Chapter 8 Institutional Review Boards
Aurea Flores

Chapter 9 Protected Health Information and Privacy in Clinical Trials
Sandra “Sam” Sather

Chapter 10 Good Pharmacovigilance Practices (GVP)
Jessica Chu

Chapter 11 Electronic Records; Electronic Signature and Data Integrity
Randall Basinger

Chapter 12 Preparing for FDA Inspections at the Sponsor
Sandra “Sam” Sather, Tommy Lee, and Jennifer Lawyer

Chapter 13 Regulations Relating to the Placebo Response in Clinical Research
Graham Bunn and Arthur Ooghe