Phase I Unit Inspection & Accreditation Programme

Phase I Unit Inspection & Accreditation Programme

Definition of Phase 1 Clinical Trial

Phase 1 clinical trial is the first stage in the clinical trial process to evaluate the safety, tolerability, and pharmacokinetics of a new drug or treatment in human subjects after preclinical testing. The primary objective of phase 1 clinical trials is to determine the maximum tolerable dose (MTD) or the recommended phase 2 dose (RP2D) of the drug or treatment.

Importance of First in Human Trials

First in human trials play a crucial role in the drug development process, and the results obtained can provide valuable information that can help in the development of new treatments, vaccines, and therapies for various diseases. First in human trials are the first time that a new drug or treatment is administered to humans, and as such, they carry a significant risk compared to other stages in the clinical development process. First in human trials are essential to establish the safety and tolerability of the drug or treatment in humans and to determine the pharmacokinetics and pharmacodynamics of the drug. First in human trials are typically conducted in healthy volunteers, and the dose is gradually increased until a maximum tolerated dose is reached. The trial is designed to determine the safety and tolerability of the drug or treatment in humans and to establish the pharmacokinetics and pharmacodynamics of the drug. In the first in human trials, the dose is gradually increased, and the escalation is usually based on the safety and tolerability of the drug. The dose escalation is typically done in cohorts, and the dose is increased until the maximum tolerated dose is reached. Safety monitoring is a crucial aspect of first in human trials, and it involves monitoring the participants for adverse events and side effects. The safety of the participants is the primary concern of the trial, and any adverse events or side effects are closely monitored and managed.

Phase I Unit Inspection & Accreditation Programme

Phase 1 inspection is an inspection of the clinical trial site to ensure that the site is complying with the regulatory requirements. The inspection is conducted by the regulatory bodies to ensure that the clinical trial site is conducting the trial in accordance with the regulatory requirements. The purpose of phase 1 inspection is to ensure that the clinical trial site is conducting the trial in accordance with the regulatory requirements. The inspection is conducted to ensure that the safety and welfare of the trial participants are protected.

 

As part of the Malaysian Economic Transformation Program (ETP), which aims to boost economic growth through clinical research, the National Pharmaceutical Regulatory Agency (NPRA) has expanded the scope of its Good Clinical Practice (GCP) inspections to include Phase 1 Units. This move creates a safe regulatory environment for the conduct of Phase I Clinical Trials in Malaysia.

 

The Phase I Unit inspection process aims to ensure that these units meet satisfactory standards for avoiding harm to clinical trial subjects and handling medical emergencies should they arise. In addition to meeting basic GCP requirements, units listed on the NPRA Phase I Program must also implement additional best practices that embrace the highest standards for avoiding harm to trial subjects and handling medical emergencies.

 

This program provides assurance to sponsors that accredited units listed can make significant contributions to enhancing the safety of volunteers and are considered to be centers of excellence for Phase I research. Phase I Units that comply with the Malaysian Guideline for Good Clinical Practice, Malaysian Guideline for Phase I Unit Inspection and Accreditation Program, and applicable regulatory requirements will be listed in the “National Pharmaceutical Regulatory Agency Phase I Unit Inspection and Accreditation Program”.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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