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A broad range of services to help your development program achieve maximum potential.

Here at PorterPharma, pharmacokinetics and ADME, both clinical and preclinical, is a core expertise. Extensive experience in all aspects of preclinical development, from bench to IND, enables us to assist in design, review and reporting of pharmacology, toxicology, or bioanalytical studies. Regulatory experience includes multiple submissions to US, EU and Canadian health authorities.

 

A broad experience base in drug development disciplines, as well as direct experience in-licensing and out-licensing drug candidates, makes PorterPharma particularly effective in due diligence reviews of potential licensing opportunities.

Phamacokinetics & ADME

PK/PD Analysis

    • NCA or modeled analysis in WinNonlin or SummitPK software
    • LC-MS/MS, ELISA, RIA, GC, and other bioanalytical data
    • Clinical, preclinical, toxicokinetics
    • Dose, regimen, route, formulation simulations
    • Food effect, gender effect, special populations
    • Sample size calculations and basic statistics (ANOVA, Student's t, etc.)
    • Deliverables include spreadsheet, plots, PowerPoint presentation, and/or full report

     

 

CYP complex

ADME

    • Study design, review, interpretation
    • Preclinical and clinical
    • In vitro and in vivo
    • Study Monitor: design overview, outsource to CRO, protocol review, on-site monitoring, report review & finalization
    • Data analysis, drug concentration or scintialltion count data
    • Outsource & monitor radiochemical synthesis
    • Review bioanalytical/metabolite ID data, reports

 

 

 

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Clinical Development

 

Indications

    • CNS (mild to moderate pain, seizure, epilepsy, TBI, others)
    • Cardiovascular (CHF, anti-coagulant therapy)
    • Metabolic disease (diabetes, osteoporosis, mitochondrial disease)
    • Auto-immune (multiple sclerosis, IBD, Crohn's, psoriasis, transplant)
    • Pulmonary (cystic fibrosis)
    • Anti-infective (herpes, etc.)
    • Oncology (glioma)
    • stethoscope
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Services

    • Study design, review, interpretation
    • PK, PK/PD data analysis & reporting
    • PK, ADME, OBA, Dose proportionality, food effect, gender effect, special populations
    • Phase I-IV
    • Clinical development plans: strategy, timing, budget, endpoints, comparators, patient population, indication, labelling
    • Best practises research
    • Standard of care research & reporting
 

Due Diligence

    • In-license and out-license experience
    • Drug candidates, drug delivery systems
    • In-depth analysis: standard of care, patient population, preclinical & clinical development challenges, SBA
    • Indication
    • Pharmacological animal models
    • Leading clinical sites (thought leaders)
    • Key risks, budget and timeline

Preclinical Development

 

Drug Discovery

    • Candidate screening & selection
    • In vitro pharmacology study design, review
    • In vitro metabolism, CaCo2 cell study design, review
    • In vivo pharmacology study design, review
    • In vivo oral bioavailability screening
    • Candidate selection criteria and path forward

IND-enabling Studies

    • Safety pharmacology
    • Acute and repeat-dose toxicology
    • Phamacokinetic: PK, PK/PD, ADME, dose, route, formulation and regimen evaluation
    • Genetic toxicology
    • Local tolerance
    • Prepare study plans (timeline, budget, amount of drug), designs, outsource & monitor at CRO, review data & reports

Phase II and Beyond

    • Reproductive toxicology
    • Long-term toxicology
    • Caricinogenicity
    • Special toxicology
 

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  Regulatory Affairs
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US FDA

    • Pre-IND briefing package & meeting
    • IND submissions (writing, compiling, submitting)
    • End of Phase II meeting
    • Strategy, labelling advice
    • NDA, BLA submissions
    • Master List
    • Document control
    • Archive
    • Agency communication
    • CTD, eCTD
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ICH

    • Familiar with all ICH guidelines
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Canada HPFB

    • CTA submission
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Europe/EU EMEA

    • CTA submission
  binders

 

 

 

 

 

 

 

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