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Waiver of In Vivo Bioavailability and Bioequivalence Studies

The BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. When combined with the dissolution of the drug product, the BCS takes into account three major factors that govern the rate and extent of drug absorption from IR solid oral dosage forms: (1) dissolution, (2) solubility, and (3) intestinal permeability.

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Dissolution Instrument Qualification

Qualification of dissolution instruments has always been challenging. The performance of the apparatus can be influenced by variability in several mechani­cal properties of the apparatus. Recently, there have been significant changes in regulatory and compen­dial guidances related to the qualification of these instruments. Despite the recent advances, there are still challenging outstanding issues. For these reasons, it is imperative that organizations that are generating dissolution data understand the challenges associated with qualification of dissolution apparatuses, become aware of the recent changes, and take steps to address the changes in their operational activities.

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Outing to Belitung

On April 7th-10th , PT. Pharma Test Indonesia held an outing to Belitung. Tanjung Tinggi, known as the shooting site of “Laskar Pelangi” movie gave a very beautiful view of large stones and blue sea. The replica of SD Muhammadiyah Gantong in the movie was also visited. Pulau Lengkuas which had a very old lighthouse (from 1882) was a primadona in this trip and it also gave a very beautiful view of Belitung from 70 meter above. Not only from the top, was the underwater life under the sea around Pulau Lengkuas very beautiful with clear water, fish and coral reefs.

The trip was ended by visiting the traditional house of Belitung and Danau Kaolin. It was a very relaxing and open-minding trip for the staffs.

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Disintegration Tester for Oral Dispersible Film

Orodispersible films (ODF) are novel dosage forms. Since 2012, they are monographed in European Pharmacopoeia. The pharmacopoeial definition says “Orodispersible films are single- or multilayer sheets of suitable materials, to be placed in the mouth where they disperse rapidly”. To determine rapid dispersion, suitable disintegration test systems are required. Other than for tablets, there is no standardized test setup available due to the novelty of the monograph. Therefore, this study aims to present two novel approaches to determine disintegration times of ODFs. One test was designed according to the pharmacopoeial tablet disintegration tester and the other to provide a system with automated end-point detection.

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Hardness Sample Position

Tablet orientation within a tablet hardness test instrument with and without sample orientation system. All round and flat or slightly concave samples are not giving any problem inside any Tablet Hardness Test instrument. No orientation device whatsoever is required.

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Pharma Test Goes To Bali 2015

On February 6th-8th, Pharma Test Indonesia Team had an outing in Bali. On the 1st day we went to Bedugul. Rather than hot and sunny day, its mountainous cool weather gave us new experience in Bali. There was a temple complex which is located facing mountains and Beratan Lake. After spending some time in Bedugul we went to Tanah Lot.

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Pharma Test Asian Sales Seminar 2015

PHARMA TEST held Asian Sales Seminar 2015 in Novotel, Nusa Dua Bali from 2nd to 6th of February 2015. The event participated by 22 representatives from 14 countries. In the Seminar, PHARMA TEST also launched some new instruments such as Dissolution Tester, Hardness Tester, Material Tester, etc. At the end of the Seminar, PHARMA TEST gave some awards for the Best Agents. Our agent from Malaysia, Matrix Analytical Sdn Bhd, received an award for “Highest Market Share”. Our agent from USA, Vortex, received an award for “Highest Increase in Market Share”. And Indonesia, represented by PT. Pharma Test Indonesia, received an award for “Highest Sales Volume Asia 2014”.

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Pharma Test release New Dissolution Tester and Hardness Tester

On 23rd-26th September, PHARMA TEST held Sales Seminar at their Headquarter in Hainburg. The event was participated by the agents from Europe and also Pharma Test’s group of companies from India and Indonesia. After the seminar, the agents also have the opportunity to visit Wuerzburg city, which located 1.5 hour from Hainburg by train. It was a good place for relaxing and discussing the future of the business.

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Pharma Test Indonesia goes to LOMBOK

All members of PT. Pharma Test Indonesia go to LOMBOK for vacation at 15th-17th of May 2014. The purpose of this vacation is to strengthen the relationship in our team and relax from the daily working activities to generate more ideas to serve the customer better. The vacation arranged by Mr. Yuli Anggoro (our technical manager) who was responsible to make all the planning.

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About Us

PT. Pharma Test Indonesia was established at the end of 2009. We are the subsidiary of Pharma Test AG (Germany) in South East Asia which supplies machines for Pharmaceutical Industry. As a part of Pharma Test commitment to Indonesian market, the company was established to fulfill the need for high quality testing equipments and supported with excellent after-sales service. Our company also supported the Pharma Test agents in South East Asia especially for the technical support.

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Contact Us

Anda bisa menghubungi kami untuk lebih detail terkait produk dan layanan kami.

PT. Pharma Test Indonesia
Komplek Mutiara Taman Palem
Blok H2/19, Cengkareng
Jakarta Barat 11730

Phone. +62 21 5694 6073
Fax. +62 21 5694 6073
Mobile. +62 851 00902797

Marketing: hans@pharma-test-indo.com
Technical Support: teknik@pharma-test-indo.com

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