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Preclinical trials:
     Development of biologically active substances (BAS) production technology
    Technological works on finished products
       Clinical trials
  • phase I
  • phase II
  • phase III
  •  phase IV
  • Comparative bioequivalence studies
         Registration of BAS and medicinal preparations
  • Development of a medicinal preparation Master File
  • Carrying out a registration procedure
    Drugs, biologically active substances, and food supplements patenting
     
Development and registration of biologically active food supplements
  • Professional design of a biologically active food supplement composition according to a clients requirements
  • A biologically active food supplement preclinical trials
  • Development of a biologically active food supplement production technology
  • Clinical trials
  • Pilot samples production
  • Development of a medicinal preparation Master File for its subsequent registration
  • Registration of a biologically active food supplement
  • Production of a biologically active food supplement in compliance with a contract concluded
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Overall solutions for drugs and biologically active food supplements production
  

Development and patenting of a generic drug
  

Development of a generic drug equivalent to a selected prototype
  

   

Development of drugs possessing prolonged action
  

Development of sublingual drugs
  

Development of liquid medicinal preparations based on a poorly soluble substance
   

Unique professional solutions of unconventional tasks in compliance with marketing specialists requirements
  

Development of a medicinal preparation Master File in compliance with European Pharmacopoeia.
  

Technological works on drugs

  

Drug formulation

Drug formulation is one of the most crucial stages of drug design.

The way and conditions of biologically active components intake into the human organism is depended on drug dosage form (drug formulation).

 

Drugs are classified by

  • 1) An aggregate condition:

    • Solid (powder, tablet, suppositories, pill, granules);
    • Liquid (true or colloidal solution, suspension, emulsion, syrup, drops and others);
    • Soft forms (ointment, gel, cream, capsule and others);
    • Aeriform (aerosol, gas);

    2) Dispersion drug classification:

    Systems without dispersing medium (tablet, pill, powder),

    Systems with liquid dispersing medium (all liquid drugs),

    Systems with soft or elastoviscous dispersing medium (ointment, paste, suppository and others),

    3) Drugs are classified by route administration:

    Enteric  oral (solution, suspension, drops, tablet, capsule and others) and through rectum (suppository),

    Parenteral (drug for skin and mucous applications, injection drugs),

    4) Dosage (tablet, capsule, pill, and ampoule) and nondosage drug forms (suspension, emulsion, ointment, gel, cream, drops, and inhalation drugs)

The main characteristics of a future drug determined during the process of drug creation are:

    • adaptability to manufacture
    • stability during production and storage
    • bioavailability (for resorptive action drugs)

    Know-how it is a drug formulation peculiarity. Formulation determines drug pharmacokinetics and its bioavailability.

    Operating by drugs formulating secrets allows reproducing a drug (so called generic) with bioavailability analogous to original one (prototype). During an innovative drug elaboration at the stage of drug formulation the future tissue drugs distribution is determined. The distribution profile (pharmacokinetics) determines a pharmacodynamics of the developed drug.

    At the stage of formulation the question of medication intake time is solved. Modern technology enables influence on the speed of API release from drug and its absorption in blood. It is possible to create a quickly dissolved (sublingual) pills or tablets with prolonged API release for example for once a day taking.

 

Development of drug production technology

Methods of raw materials and half-finished products processing, preparation, changing of state, properties and form are determined in a process of drug production technology development. At this stage the application of drug formulation process to the technical equipment is made at the laboratory and industrial level. At this step the production technology stages, operations and drug quality control procedures are developed.

The technical equipment features, the main and supplementary raw material physic-chemical properties are highly significant for drug production technology.

 

Development of drug analysis methods

In the process of drug design the analytical methods for drug identification, quantification of the API, impurities and some supplementary substances are chosen.

Selected methods should be reproducible at clients laboratories and certified drug quality control laboratories, and satisfy the requirements of national pharmacopeia.

 

Validation of analytical method

Validation of analytical method includes a set of procedures ensuring an applicability of the selected method of analysis for drug quality control.

Applicability of the method, its specificity for active substance identification and its impurities quantification are determined during a validation.

The methods linearity, the range of measurements, accuracy, repeatability, limits of measurement and reliability are also evaluated in the process of methods validation.

Report on analytic methods validation is a part of the Drug Master File.

 

Drug stability evaluation

Period of drugs validity is determined in the process of drug stability evaluation and is marked on the package and in the normative documents.

Using elevated temperature faster aging method for drugs validity period determination one can shorten the period of drug stability evaluation from several years to several months.

 

Drug specification

The main characteristic normative document of a drug is a Pharmacopoeia Monograph. It includes:

- a specification, which determines drugs quality properties, each propertys analysis methods, acceptable norms and describes the content of the main and supplementary compounds and drug form design.

- a description of methods for drug identity analysis and evaluation of drugs most significant pharmaceutical characteristics such as average mass, disintegration and solubility.

-a description of microbiological purity and the method of an active substance and impurities quantitation.

- a description of wrapping, labeling, transporting and storage patterns and validity period.

The second significant document is Technical management of drug production. Depending on a stage of development and introduction into manufacture technical management can be laboratory, startup or industrial. Technical regulations describe the sequence of stages and technical process operations of a drug production, necessary raw materials and equipment, technical process checkpoints and monitored parameters.

 

Production of pilot samples for registration/authorization procedure

At this stage the production of drug series is made at a real factory or at approximate to manufacture conditions. Drug Master File together with drug series is sent for national registration/authorization.

Samples' compliance with quality parameters shown at normative documents is checked in the process of national registration/authorization.

After permission of clinical trials by national authorities a necessary quantity of the drug is manufactured for clinics.

 

Placebo production

Placebo is a drugs analogue of the same shape but without of API.

Placebo is used in clinical trials carried out by double blind method. In the process of efficiency and safety test on volunteer patients neither doctor nor patient knows where a drug or placebo is applied. Only statistic method of clinical trials analysis makes it possible to evaluate the real drug efficiency and safety.

2008-2012 
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