Join Medicilon at the Applied Pharmaceutical Analysis (APA) 2023

We are excited to announce that Medicilon will exhibit at the Applied Pharmaceutical Analysis (APA) 2023 from September 26-28 in Boston, MA. We are happy to meet you in person to discuss how our services and capabilities can support your research and expedite your drug discovery and development activities. We will present a poster titled "The Boost of DMPK and Bioanalysis for Drug Discovery and Development".

Date: September 26-28, 2023

Location: Merck Research Laboratories, Boston, MA

Welcome to our booth (#1) to view the full version of the poster

About Applied Pharmaceutical Analysis (APA)

Applied Pharmaceutical Analysis (APA) was formed in 2004 by The Boston Society (a 501(c)3 non profit) as an industrially-focused and highly interactive forum on Bioanalysis in Drug Discovery, Biotransformation and Regulated Bioanalysis which meets annually in September. Each year different scientific leaders meet regularly to help plan a solid agenda based on cutting edge technologies and best practices of Bioanalysis and Biotransformation of Drug Discovery and Development. This group is open to all interested scientists.

APA 2023 Sessions

❖Regulated Bioanalysis Workshop

Session I: Assessing the Current Landscape of FDA Regulations

Session II: Advances in Sampling Strategies: A dialogue with Joleen White & Lori Payne

Session III: Emerging Modalities & New Technologies

Session IV: Immunogenicity Applications for Various Drug Modalities

Session V: Rapid Fire Poster Presentations

❖Discovery Bioanalysis and New Technologies Workshop

Session I: Leveraging Biomarkers & Integrating Multi-Omics for Biomarker Discovery

Session II: Applications of Precision Medicine in Drug Discovery Research

Session III: Advancing DMPK/Bioanalysis of PROTAC's

Session IV: Latest Advances in LC-MS

❖Mechanistic ADME Workshop

Session I: ADME of Select Modalities

Session II: Why is My Human ADMET Profile Not as Expected?

Session III: Applying Cutting-edge ADME Technologies

Session IV: Exploring Unconventional Biotransformation Pathways

Medicilon ADMET and PK Services

According to reports, over 80% of investigational new drugs fail during development because of unsatisfactory ADME characteristics. The ADME research can greatly impact clinical success, and early assessment of ADME characteristics has real value in improving the drug discovery and development process.

Pharmacokinetic is a subject that quantitatively studies the absorption, distribution, metabolism and excretion of drugs in organisms, and uses mathematical principles and methods to explain the laws of changes in blood drug concentration over time. Drug metabolism and pharmacokinetics (DMPK) is an important branch of pharmaceutical sciences. The nature of ADME and PK inquiries during drug discovery and development has evolved in recent years from being largely descriptive to seeking a more quantitative and mechanistic understanding of the fate of drug candidates in biological systems.  Dramatic increases in investments on new modalities beyond traditional small and large molecule drugs, such as peptides, oligonucleotides, and antibody-drug conjugates, necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME properties. Bioanalytical support plays a vital role during the lead optimization stages. The major goal of the bioanalysis is to assess the over-all ADME characteristics of the new chemical entities (NCE’s). Bioanalytical tools can play a significant role for the progress in drug discovery and development.

Medicilon’s pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and etc.

In vitro ADMET

❖Liver microsome / S9 / Hepatocyte stability

❖CYP450 enzyme inhibition & TDI

❖CYP450 enzyme induction

❖Enzyme phenotype analysis

❖Plasma protein binding

❖Plasma (serum) stability

❖In vitro MetID and metabolic pathways

❖GSH-trapping

❖Whole blood / plasma distribution

❖Permeability and efflux

❖Transporters

❖(Pgp/BCRP/OATs/OCTs/OATPs/MATEs/BSEP)

❖BBB penetration,Kp,uu

❖hERG

❖Mini-Ames

In Vivo PK & Non-GLP Tox              

❖Species：Mouse (ICR, C57, balb/c, SCID, Nude mouse), Rat (SD, Wistar), Guinea pig, Mini-pig, Rabbit, Canine (beagle dog), Cynomolgus monkey

❖Administration Routes: Intravenous (IV), Per os (PO), Subcutaneous (SC), Intramuscular (IM), Intraperitoneal (IP), Topical, Transdermal, IT etc.

❖Dose Strategies: Single, multiple and cassette dosing

❖Serial blood microsampling

❖In vivo metabolite identification and quantitation

❖Tissue distribution

❖Mass balance with excretion

❖Pre-formulation screening

❖PK/PD & human PK modeling

❖Non-GLP Tox, MTD, DRF (Safety window)

❖¹²⁵I/¹⁴C/³H labeled isotope drug metabolism and mass balance studies

❖Surgical techniques: Venous cannulation, biliary cannulation, infusion pump, liver/muscle biopsy and implantation

Medicilon offers a full suite of in vivo (‘in animal’) ADME (absorption, distribution, metabolism, and excretion) and PK (pharmacokinetic) services, featuring an in vivo team with near 20 years of experience.

Medicilon maintains an AAALAC International-accredited facility with clean rooms for cell culture, an animal care vivarium, and a large variety of instrumentation to perform IND-enabling (Investigational New Drug application) studies to support your compound’s development.

Medicilon offers you our expertise in DMPK & non-GLP/GLP bioanalysis, to support you in the complete characterization of the ADME properties and the evaluation of the toxicity of your future clinicate candidate.

From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in America, Europe and Asia. Our highly trained scientists utilize a range of leading-edge technology, automation and state-of-the-art techniques.

#ADME #PK #APA2023 #Bioanalysis