Safety Regulatory Package: GLP Pharmacology
Adherence to Good Laboratory Practice (GLP) in drug development transcends regulatory requirements; it embodies a profound commitment to safety and quality. As a global contract research organization, Porsolt’s Safety Regulatory Package, focused on GLP pharmacology, epitomizes this dedication, ensuring that every facet of drug development aligns with the highest standards of safety and efficacy.
GLP Pharmacology: Ensuring Drug Safety through Rigorous Compliance
At the core of our Safety Regulatory Package lies GLP pharmacology, a critical element in ensuring the safety of pharmaceuticals. This branch of our services offers a spectrum of studies, each meticulously designed and executed to align with the stringent compliance requirements of GLP safety in nonclinical laboratory settings.
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SAFETY REGULATORY PACKAGE
Behavioral Pharmacology Studies
Behavioral Pharmacology Studies, essential for testing abuse and dependence potential, are conducted under strict regulations as a key component of GLP in preclinical studies within a GLP safety pharmacology package.
| Conditioned place preference | Rat |
| Drug discrimination | Rat |
| Non-precipitated withdrawal(option: telemetry) | Rat |
| Self-administration (initiation) | Rat |
| Self-administration (substitution) | Rat |
Core Battery [ICH S7]
The Core Battery [ICH S7] in GLP preclinical settings meticulously studies the effects of a test substance on critical physiological functions, encompassing the cardiovascular, respiratory, and central nervous systems.
CARDIOVASCULAR ACTIVITY RECORDING
IN VITRO MODELS| hERG channel | HEK 293 cells |
| Purkinje fiber | Rabbit – Dog |
CARDIOVASCULAR STUDIES IN CONSCIOUS ANIMALS
| Arterial blood pressure, heart rate and ECG | Mouse – Rat – Dog - Guinea-pig – Mini-pig |
CENTRAL NERVOUS SYSTEM STUDIES
| Activity meter | Mouse – Rat |
| Primary observation (Irwin) | Mouse – Rat |
| Rotarod | Mouse – Rat |
RESPIRATORY STUDIES
| Airway function (whole body plethysmography) | Mouse – Rat - Guinea-pig |
Formulation Analysis
Formulation analysis, a vital component of GLP pharmacology, adheres to Standard Operating Procedures to ensure precise dose concentrations in GLP safety studies.
Porsolt’s extensive range of models and services, including the Pharmacokinetics test and encompassing various indications, enables us to conduct thorough testing and follow-up analysis of your project, adhering to stringent regulation standards as part of a broader scope of studies in your development program.
Method transfer or development
Method validation:
- specificity - accuracy
- linearity - precision,…
Stability evaluation
(stock and dosing formulations)
Adsorption evaluation
(for in vitro studies)
Formulation analysis:
- concentration verification
- homogeneity of formulations
Supplemental Studies
Supplemental Studies involve the study and control of a test substance's effects on additional vital physiological functions, extending beyond the Central Nervous, Cardiovascular, and Respiratory Systems, as part of comprehensive testing in GLP safety assessments.
| Autonomic nervous system | Rat |
| Cardiovascular studiesin anesthetized animals | Multiple species |
| Gastrointestinal system | Multiple species |
| Renal function | Mouse – Rat |
| Cardiomyocytes | iCell²® |
| Spontaneously beating right atrium | Guinea-pig – Rabbit |
| Stimulated left atrium | Guinea-pig – Rabbit |
Comprehensive GLP Preclinical and Non-Clinical Studies
Our GLP preclinical and non-clinical studies lay the groundwork for the drug development process. These studies are meticulously designed to provide robust data, forming a solid foundation for subsequent phases of drug development. We go beyond standard assessments, incorporating advanced methodologies to understand the nuances of side effect and toxicological responses. This includes a detailed evaluation of drug safety, from initial in vitro assessments to extensive in vivo analyses, ensuring a thorough understanding of a drug’s safety profile.
Ensuring Safety and Compliance in Every Step
Safety and compliance are at the heart of our operations. Our GLP safety services encompass a wide range of evaluations, ensuring that every potential safety concern is thoroughly investigated.
This includes GLP toxicology studies, which are characterized by their rigorous evaluation processes. We also ensure that our laboratory practices meet the highest standards of GLP and lab safety, providing a safe and controlled environment for all our research activities.
Porsolt’s Proficiency in GLP Pharmacology
At Porsolt, our proficiency in GLP pharmacology is anchored in a steadfast commitment to precision and innovation. Our team, comprising experienced professionals, rigorously adheres to Standard Operating Procedures, ensuring that every step of the organizational process aligns with the highest standards of GLP and lab safety.
Utilizing innovative methodologies, we are dedicated to conducting comprehensive safety pharmacology studies. Our approach involves advanced techniques to yield reliable and accurate results, which are essential at various times throughout the drug development process.
Advancing Drug Safety and Development
The meticulous evaluation of GLP pharmacology represents a crucial phase in the journey towards creating safer and more efficacious therapeutics. In this endeavor, Porsolt’s Safety Regulatory Package exemplifies the highest standard in drug development.
Our unwavering dedication to GLP pharmacology underscores our commitment to enhancing healthcare through thorough and ethical scientific research. More than just a service provider, Porsolt stands as a committed partner in the pursuit of developing safe and effective pharmaceuticals.
