Genesis Drug Discovery & Development (GD3)的动态

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

Do you have an ocular therapeutic candidate for which you need safety assessment and toxicology data? The scientists at GD3 have extensive experience collecting and interpreting routine ocular readouts following test article administration through a variety of dose routes, including topical, intravitreal, subretinal and suprachoroidal. Using our state-of-the-art Heidelberg Spectralis HRA + OCT device, we can generate high-quality and consistent optical coherence tomography (OCT), fluorescein angiography (FA) and confocal scanning laser ophthalmoscopy (cSLO) data needed to continue advancing your therapeutic candidate through the drug development pipeline. The experts at GD3 are able to take these readouts a step further by quantitatively assessing visual function through the collection of electroretinograms (ERG) using our Celeris Diagnosys system, which enables our experts to execute the standard International Society for Clinical Electrophysiology of Vision (ISCEV) protocol that is routinely used in clinical studies. At GD3, we are invested in understanding the characteristics of your therapeutic candidate. We can offer guidance and expertise on standard OCT and ERG parameters required to assess ocular safety and toxicology, which can be modified to satisfy client and therapeutic candidate needs. Additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 include: ???? We offer additional ocular safety assessment and toxicology readouts that are routinely performed and offered at GD3 including: ? Indirect and slit lamp ocular examinations performed by a board-certified veterinary ophthalmologist ? Intraocular Pressure ? Pachymetry ? Modified Draize Scoring ? Depot imaging ? Data interpretation and summary of ocular readouts performed by a board-certified veterinary ophthalmologist ? Histopathological assessment with a board-certified pathologist ? Biomarker evaluation ? Gene expression analysis ? Bioanalysis for small molecules, peptides, proteins and nucleic-acid-based therapeutics ?? Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/eRPXDeQz

CTD module 5 - Phase 1 design From the data gathered in Pre-clinical stage (CTD module 4) in animals such as: - Toxicology in 2 differents species - Toxicokinetics - LD50 (Lethal Dose) - Mutagenicity - Reproductive toxicology (Rabbit or rat is much more convenient because of its high reproductive rate) - Safety pharmacology - Absorption, distribution, metabolism, and excretion of the drug: AUC (Area Under the Curve), Distribution volume, Histopathology in different organs such as Liver, kidney, brain or other of interest, metabolites (pre-drug, secondary active metabolites, toxic product, CYP enzyme induction/inhibition, etc.). The subjects involved in this phase are a small group of 20 to 100 healthy volunteers, typically men or those with the disease/condition. These participants will receive a “first in human” single dose of a new drug, usually orally or intravenously, and will be monitored for safety. The starting dose of a drug is based on the outcome of preclinical research studies in animals. The starting dose is very low and is administered once to ensure the safety of the participants. The typical dose design is progressive increasing one, which is relatively safer for all stakeholders. Among of all participants, a small portion will be under Pharmacokinetics (PK) and Pharmacodynamics (PD) examination. Administration plan will be progressive adjustable one: increasing the dose of the drug and/or the frequency of the dose administered. In single ascending dose (SAD) studies, volunteers will receive a single increased dose of the drug. In multiple ascending dose (MAD) studies, volunteers will receive multiple doses of the drug. After these adjustments, the safety of the volunteers will be reviewed again based on additional tests performed. The results of phase I will be: - The safest dose of the drug - Any potential adverse side effects - Toxicity of the drug - The overall safety of the drug in humans

Despite running a recommended battery of?in vitro?assays, unanticipated toxicity?during early nonclinical testing of a new therapeutic?occurs.??If looking for a case example, look no further than?the International Journal of Toxicology article "Electrophysiological Changes in the Rabbit Ventricular Wedge and Human-Induced Pluripotent Stem-Cell Derived (IPSC) Cardiomyocytes Translate to Severe Arrhythmia Observed in a Canine Toxicology Study, Not Predicted by Standard in Vitro Ion Channel Assays".?The article helps guide the researcher on next steps. ? Link to the article:?https://lnkd.in/e3QZsBHr ? For the College's policy on the ethical treatment of animals in research, please see the ACT comprehensive policy statement at?https://lnkd.in/eznYnkJf?and please consider that other approaches might be available.

Quantitative Pharmacology of Anti-bacterial Agents The pharmacology of anti-bacterial agents can be quantitated in two ways: 1.?????Static PK/PD models which integrate PK with in vitro potency (MIC, MBC) – PK/PD index associated with efficacy 2.?????Dynamic PK/PD models which link PK with growth and killing of bacteria – onset, intensity and duration of effect. Static PK/PD models have been extensively used for characterization of PK/PD of anti-bacterial drugs and also to set clinical PK/PD targets for achieving microbiological and clinical cure. Characterizing the PK/PD of lead compounds prior to the optimization stage can be very useful in determining the intrinsic PK/PD properties. Understanding the PK/PD properties can help in 1.?????assessing the potential of the lead series and in prioritizing them for progression to optimization. 2.?????Prediction of efficacy based on MIC and PK 3.?????estimating the dose, dose frequency and duration of treatment for the drug candidates, which in turn can be scaled to humans. https://lnkd.in/ghExjbvq