Analytical Techniques for Clinical Chemistry
Methods and Applications
Sergio Caroli, Gyula Záray, Sergio Caroli, Gyula Záray
- English
- ePUB (mobile friendly)
- Available on iOS & Android
Analytical Techniques for Clinical Chemistry
Methods and Applications
Sergio Caroli, Gyula Záray, Sergio Caroli, Gyula Záray
About This Book
Discover how analytical chemistry supports the latest clinical research
This book details the role played by analytical chemistry in fostering clinical research. Readers will discover how a broad range of analytical techniques support all phases of clinical research, from early stages to the implementation of practical applications. Moreover, the contributing authors' careful step-by-step guidance enables readers to better understand standardized techniques and steer clear of everyday problems that can arise in the lab.
Analytical Techniques for Clinical Chemistry opens with an overview of the legal and regulatory framework governing clinical lab analysis. Next, it details the latest progress in instrumentation and applications in such fields as biomonitoring, diagnostics, food quality, biomarkers, pharmaceuticals, and forensics. Comprised of twenty-five chapters divided into three sections exploring Fundamentals, Selected Applications, and Future Trends, the book covers such critical topics as:
- Uncertainty in clinical chemistry measurements
- Metal toxicology in clinical, forensic, and chemical pathology
- Role of analytical chemistry in the safety of drug therapy
- Atomic spectrometric techniques for the analysis of clinical samples
- Biosensors for drug analysis
- Use of X-ray techniques in medical research
Each chapter is written by one or more leading pioneers and experts in analytical chemistry. Contributions are based on a thorough review and analysis of the current literature as well as the authors' own firsthand experiences in the lab. References at the end of each chapter serve as a gateway to the literature, enabling readers to explore individual topics in greater depth.
Presenting the latest achievements and challenges in the field, Analytical Techniques for Clinical Chemistry sets the foundation for future advances in laboratory research techniques.
Frequently asked questions
Information
Summary
1.1. Introduction
1.2. Good Clinical Practice
1.2.1. ICH E6: Guidelines for Good Clinical Practice
- CTs should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirements.
- The rights, safety, and well being of trial subjects are the most important considerations and should prevail over interests of science and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- Freely given informed consent should be obtained from every subject prior to CT participation.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed CT.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his/her respective task(s).
- Investigational products should be manufactured, handled, and stored in accordance with applicable Principles of GMP. They should be used in accordance with the approved protocol.
- All CT information should be recorded, handled, and stored in a way that allows for its accurate reporting, interpretation, and verification.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.
- CTs should be scientifically sound and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval/favorable opinion.
- Systems with procedures that assure the quality aspects of the trial should be implemented.
- The investigator/institution should maintain the trial documents as specified in “Essential Documents for the Conduct of a Clinical Trial” and as required by the applicable regulatory requirement(s). The investigator/institution should take measures to prevent accidental or premature destruction of these documents (par. 4.9.4).
- The sponsor is responsible for implementing and maintaining Quality Assurance (QA) and Quality Control (QC) systems with written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s) (par. 5.1.1).
- QC should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly (par. 5.1.3).
- If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development, the results of any additional studies of the formulated product(s) (e.g., stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials (par. 5.13.5).
- The sponsor should