자유게시판

• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

Glucagon-like peptide-1 (GLP-1) reduces insulin requirement in diabetes mellitus and promotes satiety. GLP-1 in the periphery (outside the CNS) has been shown to act on the brain to reduce food ingestion. GLP-1, an analog with similar biological effects and greater stability, with the blood-brain barrier (BBB). 0.798 x 10(4) mL/g-min as measured by multiple-time regression analysis after iv injection in mice. GLP-1 either iv or MedicGLP by in situ brain perfusion, indicating the absence of a saturable transport system at the BBB. 3. Lack of modulation by short-term fasting and some other ingestive peptides that may interact with GLP-1, including leptin, glucagon, insulin, neuropeptide Y, and melanin-concentrating hormone. 4. No inhibition of influx by the selective GLP-1 receptor antagonist exendin(9-39), suggesting that the GLP-1 receptor is not involved in the rapid entry into brain. GLP-1 to exit the brain other than following the reabsorption of cerebrospinal fluid (CSF). The fast influx was not associated with high lipid solubility. GLP-1 entered the brain parenchyma, but a large proportion was loosely associated with the vasculature at the BBB. GLP-1 was compared with that of GLP-1 in a blood-free brain perfusion system; radiolabeled GLP-1 had a more rapid influx than its analog and neither peptide showed the self-inhibition indicative of a saturable transport system. GLP-1 and the endogenous peptide GLP-1 can gain access to the brain from the periphery by simple diffusion and thus contribute to the regulation of feeding.

I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there was a need to provide guidance to GLP facilities that would allow them to utilise modern quality risk assessment techniques in support of the conduct of GLP studies. This has become particularly apparent for those facilities engaged in activities that require compliance with other quality systems in addition to GLP, such as GMP and GCP. Having a risk-based GLP QA programme should offer facilities the flexibility to focus their resources in areas that present the biggest risk to their compliance status. During the last 13 years of inspecting I have been asked on many occasions how much is enough when it comes to QA. The answer to this question is not necessarily about the number of QA inspections conducted, it is about whether they add value in terms of assuring compliance.

Also, are the inspections effective at identifying problems before they have a serious impact on the integrity of the data, compliance of the study or the facility as a whole? What’s right for one facility may not be right for another. The size of the facility, number of staff, amount of GLP work and the other quality systems in place are key factors in determining how much is enough. For example, the procedures for handling and dealing with deviations, amendments, errors, change etc. These systems can generate a lot of data - what does it tell you and how is it used? The challenge of course is to make sense of the data you have and turn it into meaningful information in order that you can make decisions as to how much QA is enough. Ultimately, the answer is to understand your processes and know where the risks are, then design your QA programme accordingly.

The UK GLPMA in consultation with UK stakeholders have produced a guidance document that is designed to support GLP facilities to devise and MedicGLP Weight Management develop their QA programmes to best suit their individual business needs, while retaining the highest possible standards of GLP compliance specific to their GLP activities. The document provides updated definitions of study, Medic GLP Supplement process and facility inspections. It also includes the concept of risk MedicGLP Weight Management and quality control in a GLP setting. Although there is no mandatory requirement or expectation that all facilities adopt this approach, we would hope that key aspects of the guidance will prove useful to a facility in improving their current QA programme, and ensuring that inspections and associated activities are appropriate to each facility and add value rather than being just a box ticking exercise. Risk management is about identifying what the risks to compliance are and having an understanding of the impact of the risk. This initial review should be followed by an assessment of procedures, processes and systems to control, monitor and mitigate the risk.