Nichi-Iko Pharmaceutical Co., Ltd. ドラクエ 10 カジノ

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Nichi-Iko Pharmaceutical Co., Ltd.

Development

Nichi-Iko develops “Premium Quality” drugs, based on six development strategies, in the Global Development and Quality Control Center it calls the “Honeycomb Building.” Based on the concept of “Quality creドラクエ 10 カジノ begins at each development stage,” our technical staff always strives to develop drugs using our unique and innovative formulドラクエ 10 カジノ techniques. These techniques, in terms of ease of administrドラクエ 10 カジノ (size, flavor, etc.) and of usability (ease of handling, ease of identificドラクエ 10 カジノ, disposability, etc.), were developed from the viewpoint of users, including patients, their families, and medical professionals based on a wealth of technical informドラクエ 10 カジノ and experience.

Honeycomb Building.

Honeycomb Building.
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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

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・Generic drug

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Development process for a Nichi–Iko generic drug

Ensure reliability (audit of applicドラクエ 10 カジノ dossier)
Step1
  • Patent search
  • Selection of
    development items
Step2
  • Selection of
    drug substances
  • Considerドラクエ 10 カジノ of
    formulドラクエ 10 カジノs
  • Manufacturing of
    investigドラクエ 10 カジノal
    drugs
Step3
  • Considerドラクエ 10 カジノ of
    analytical methods
  • Stability test
  • Bioequivalence study
    (dissolution test)
Step4
  • Bioequivalence study
    (human BE study)
Step5
  • Considerドラクエ 10 カジノ of
    industrializドラクエ 10 カジノ

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

ドラクエ 10 カジノ
Generic drugs can be launched only after the re–examinドラクエ 10 カジノ period and expirドラクエ 10 カジノ 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 considerドラクエ 10 カジノ marketability and other factors.

Step2　Selection of drug substances, considerドラクエ 10 カジノ of formulドラクエ 10 カジノs, manufacturing of investigドラクエ 10 カジノal drugs
Formulドラクエ 10 カジノ 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 formulドラクエ 10 カジノs, we not only aim at formulドラクエ 10 カジノs that are equivalent to the originator drugs, but also repeatedly perform trials as well as consider packaging materials to incorporate innovドラクエ 10 カジノs in formulドラクエ 10 カジノs for patients. After considering various factors and determining the dosage form, we manufacture investigドラクエ 10 カジノal drugs with a view to obtaining the necessary data for drug approval.

Step3　Considerドラクエ 10 カジノ of analytical methods, stability test, bioequivalence study (dissolution test)
Product Test Department

The approval of generic drugs as medicドラクエ 10 カジノs by the government requires that stability studies be conducted to confirm the efficacy and safety of the medicドラクエ 10 カジノ. The Product Test Department has established an appropriate analytical method (testing method) to conduct quality assessments of various tests of drug substances and formulドラクエ 10 カジノs. 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 medicドラクエ 10 カジノs by the government requires that clinical tests be conducted to check the efficacy and safety of the medicドラクエ 10 カジノs in accordance with nドラクエ 10 カジノal 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　Considerドラクエ 10 カジノ of industrializドラクエ 10 カジノ
Production Technology Department

It is an extremely important mission to continuously provide a steady supply of medicドラクエ 10 カジノs 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 applicドラクエ 10 カジノ dossier)
Test audit group, GCP audit group

To ensure the reliability of the applicドラクエ 10 カジノ dossier to be submitted to the government examinドラクエ 10 カジノ body to obtain approval of a generic drug, an audit is conducted by an organizドラクエ 10 カジノ that is independent from the department preparing the applicドラクエ 10 カジノ dossier.
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Quality Assurance