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目前显示的是 七月, 2021的博文

Bioanalytical Laboratory Services of Medicilon

 The Bioanalysis Department of Medicilon provides a comprehensive bioanalytical services compliance with FDA/OECD/CFDA GLP requirement. With a capacity to analyze more than 250,000 samples per year, Medicilon is uniquely positioned to handle the demands of “fast PK studies” in a wide variety of animal matrices in order to provide streamlined fast feedback using appropriate methods. In the highly competitive environment of drug discovery , turnaround time can make a huge difference in solving important issues in human health. The elucidation of structure activity relationships (SAR) in drug discovery settings requires fast feedback for the understanding of PK/PD properties as determined in appropriate model species. Medicilon has established over 100 different cancer cell lines for cell-based assays. Respect for and containment of our client’s vital IP is always at the center of our operations. Medicilon is well positioned to handle even the most demanding screening programs and

Pharmaceutical Preformulation Studies

  Preclinical Candidate Characterization Solubility : – pH Solubility Profile – Solubility in Organic Solvents – Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF) Stability: – Solution Stability, Solid State Stability, ICH Photostability Inherent Properties: – pKa, Log p/Log D, Intrinsic dissolution, etc. Enabling Formulation Development for Screening     – Vehicle Selection – pH Adjustment and Co-Solvent – Surfactant Solubilization – Nanosuspension – Microemulsion – Amorphous Solid Dispersion Medicilon brings the right equipment, facilities and highly dedicated formulation specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.  For more details, please click  preformulation studies . Preformulation is a branch of pharmaceutical sciences that utilizes biopharmaceutica

Hit Identification in Drug Discovery

  Medicilon’s Chemistry department has more than 100 chemists, who are experienced in the cooperation with major domestic and international pharmaceutical and biotech companies. Our services cover a variety of research interests in novel  drug research , including  target validation , hits evaluation,  lead optimization , candidate nomination,  preclinical development  and  IND filing . Medicilon has completed dozens of  drug research projects  for clients and successfully identified several  drug candidates  for clinical trials. Our team provides the following services: Target Assessment –  Drug Targets HITs Identification Lead Optimization Clinical Candidate Nomination Computer Aided  Drug Design SAR Study Hit discovery technologies  range from traditional high-throughput screening to affinity selection of large libraries, fragment-based techniques and computer-aided de novo design, many of which have been extensively reviewed. Development of quality leads using hit confirmation and

Fluorescent Antibody Technique (Direct, Indirect)

  What is Fluorescent Antibody Technique (Direct, Indirect)? Test for tissue antigen using either a direct method, by conjugation of antibody with fluorescent dye ( fluorescent antibody technique, direct ) or an indirect method, by formation of antigen-antibody complex which is then labeled with ( fluorescent antibody technique, indirect ). Direct Fluorescent Antibody Test Principles Fluorescence microscopy requires a special type of light source, usually a mercury lamp. The light from the lamp passes through special colored filters which only allow light with distinct wavelengths to pass. When this narrow band of light hits the specimen, certain compounds in the specimen (either natural compounds or added fluorescent chemicals) capture the light and reflect it back up as light with a lower energy. This reflected light is detected either with the viewer’s eye, or with sensitive detectors. Because this type of microscopy uses reflected light on a dark background, very small amounts of l

What is Toxicokinetics?

  Toxicokinetics   is essentially the study of “how a substance gets into the body and what happens to it in the body”.   Four processes are involved in toxicokinetics. Four processes in toxicokinetics The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition,  toxicology studies  were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms  toxicokinetics ,  pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ bio

Preclinical Drug Development Process

  Preclinical Drug Development Process Drug development  is time consuming and costly which contains  preclinical , clinical and after-market. In principle, if all the processes are straight-forward, a drug can be developed in a seven year period. In practice,  drug development  takes in excess of twelve years. Procedures are tightly regulated both for safety and to ensure drugs are effective. Of the many compounds studied with the potential to become a medicine, most are eliminated during the initial research phases. Clinical trials follow extensive research using in vitro and animal studies. Even so, many drugs are withdrawn or fail, never becoming approved as medicines. Common reasons include side-effects, the drug proving less effective than hoped or lacking financial viability. Preclinical Drug Development Process In  drug preclinical development , also named  preclinical studies  and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans