Development

Process up to completion of a Nichi–Iko generic drug

Generic drugs can be launched in a shorter development period and at lower development costs compared to originator drugs (new drugs). However, many processes described below are required up to the launch of the generic drugs.

・New drug

・Generic drug

Development process for a Nichi–Iko generic drug

Ensure reliability (audit of application dossier)

Step1

Patent search
Selection of
development items

Step2

Selection of
drug substances
Consideration of
formulations
Manufacturing of
investigational
drugs

Step3

Consideration of
analytical methods
Stability test
Bioequivalence study
(dissolution test)

Step4

Bioequivalence study
(human BE study)

Step5

Consideration of
industrialization

Step1　Patent search, selection of development items
Development and Planning Department

Generic drugs can be launched only after the re–examination period and expiration of the patent of their originator drugs, among other things. The Development and Planning Department conducts such patent searches as well as selects candidate items for development while taking into consideration marketability and other factors.

Step2　Selection of drug substances, consideration of formulations, manufacturing of investigational drugs
Formulation Development Department

The selection of drug substances is of utmost importance in manufacturing high–quality generic drugs. At Nichi–Iko, we use carefully selected high–quality drug substances that can be obtained in a steady supply from several manufacturers in Japan and abroad. In considering formulations, we not only aim at formulations that are equivalent to the originator drugs, but also repeatedly perform trials as well as consider packaging materials to incorporate innovations in formulations for patients. After considering various factors and determining the dosage form, we manufacture investigational drugs with a view to obtaining the necessary data for drug approval.

Step3　Consideration of analytical methods, stability test, bioequivalence study (dissolution test)
Product Test Department

The approval of generic drugs as medications by the government requires that stability studies be conducted to confirm the efficacy and safety of the medication. The Product Test Department has established an appropriate analytical method (testing method) to conduct quality assessments of various tests of drug substances and formulations. In addition, the Product Test Department conducts dissolution test that compares the dissolution characteristics of active ingredients to confirm the equivalent quality of originator drugs and generic drugs.

Step4　Bioequivalence study (human BE study)
Clinical Test Department

The approval of generic drugs as medications by the government requires that clinical tests be conducted to check the efficacy and safety of the medications in accordance with national standards. The Clinical Test Department confirms the process of active ingredients being absorbed in the body and disappearing from the body (pharmacokinetics) when a human takes an originator drug and a generic drug, for the purpose of checking the generic’s equivalent efficacy and safety compared to the originator drug.

Step5　Consideration of industrialization
Production Technology Department

It is an extremely important mission to continuously provide a steady supply of medications to patients and medical professionals. Production Technology Department provides technical support for the production of drugs manufactured at each plant and contributes to the stable supply by considering the scale-up of production up to a commercial scale.

Ensure reliability (audit of application dossier)
Test audit group, GCP audit group

To ensure the reliability of the application dossier to be submitted to the government examination body to obtain approval of a generic drug, an audit is conducted by an organization that is independent from the department preparing the application dossier.

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Quality Assurance