ICH Q6A GUIDELINE PDF

Quality Guidelines. /ICH Guidelines; /Work Products; / Home. Harmonisation achievements in the Quality area include pivotal Q6A- Q6B Specifications. With this guideline on specifications and testing methods of new active substances and medicinal products ICH intends to make possible the compilation of a. ICH Q6A specifications: Test procedures and acceptance criteria for new drug The former guideline identifies the limits that are placed on Class 1, 2 or 3.

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Quality Guidelines

Since reaching Step 4 inworldwide experience with implementation of the ICH Q11 Guideline and its recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials. In addition, guidance is provided in Q3D on how to develop an acceptable level for EIs for drug products administered by other routes of administration.

It extends the main stability Guideline for new formulations of already approved medicines and defines guiddline circumstances under which reduced stability data can be accepted. Q14 Analytical Procedure Development Guideline The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process.

Consequently, the ICH SC considered that the development of a comprehensive training programme and supporting documentation sponsored by ICH was necessary to ensure the proper interpretation and effective utilisation by industry and regulators alike to enable a harmonised and smooth implementation of Q3D on a global basis.

The document does guidelne prescribe any particular analytical, nonclinical or clinical strategy.

Quality Guidelines : ICH

For further information, including the Concept Paper and Business Plan, please follow the link here. This document provides guidance on justifying and setting specifications for proteins and polypeptides which are derived from recombinant or non-recombinant cell cultures.

This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

The Guideline specifically deals with those impurities which might arise as degradation products of the drug substance or arising from interactions between drug substance and excipients or components of primary packaging materials. Microbial Enumeration Tests General Chapter. The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage.

Threshold values for reporting and control of impurities are proposed, based on the maximum daily dose of the drug substance administered in the product.

Q4B Annex 4B R1. Q4B Annex 7 R2.

Q4B Annex 5 R1. This Guideline has been first revised and finalised under Step 4 in February Q4B Annex 4A R1. Q4B Annex 8 R1. Q4B Annex 1 R1. Tests for Specified Micro-organisms General Chapter. Following favourable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation.

The ICH Steering Committee receives regular reports on the status of pharmacopoeial harmonisation at its meetings. Q3D R1 – Step 2 Presentation. Q4B Annex 4C R1. Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice GMP risk management.

This guideline might also be appropriate for other types of products. Q4B Annex 9 R1. Account has been taken of the considerable guidance and background information which are present in existing regional documents. The main emphasis of the document is on quality aspects.

Where a company chooses to apply quality by design and quality risk management Q9: The Guideline sets out a rationale for the reporting, identification and qualification of such impurities based on a scientific appraisal of likely and actual impurities observed, and of the safety implications, following the principles elaborated in the parent Guideline.

Q14 Analytical Procedure Development Guideline. This Guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

The annex is not intended to establish new standards: The correction was integrated in the Guideline that was then renamed Q5A R1. Q2 R1 Validation of Analytical Procedures: This new guidance is proposed for Active Pharmaceutical Ingredients APIs harmonising the scientific and technical principles relating to the description and justification of the development and manufacturing process CTD sections S 2.

This new Guideline is proposed to:

JOMBLO SEBUAH KOMEDI CINTA PDF

Directed by Hanung Bramantyo. With Arie Kriting, Richard Kyle, Deva Mahenra, Aurélie Moeremans. Singles is about four companions Agus (Sunda), Bimo. DOWNLOAD JOMBLO SEBUAH KOMEDI CINTA ADHITYA MULYA. Page 1. Page 2. A Grammar of the English Language – A Few Words: Words Are Small. DOWNLOAD JOMBLO SEBUAH KOMEDI CINTA ADHITYA MULYA. Page 1. Page 2. German aircraft landing gear a detailed study of german world war ii.

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ERMENI TEHCIRI YUSUF HALAOLU PDF

Author: Halaçoğlu, Yusuf [Browse]; Format: Book; Language: Turkish; Published/ ​Created: Ankara: Türk Tarih Kurumu, Description: x, p., [42] p. of. Yusuf Halaçoğlu has 11 books on Goodreads with ratings. Yusuf Halaçoğlu’s most popular book is تهجير الأرمن (): الوثائق والحقيقة. Ermeni tehciri by Yusuf Halaçoğlu(Book) 11 editions published between and in Turkish and held by 25 WorldCat member libraries worldwide.

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The first is largely factual and broadly examines the Armenian issue in Anatolia from the late 19th Century to the present day.

Books by Yusuf Halaçoğlu (Author of Ermeni Tehciri)

Greenwood, Keith, Robert College: Princeton University Press,p. This kind of placement continued till the end of the war. A few points must be raised about the style and terminology used in this dissertation. This dissertation will also examine the views of certain Turkish Armenians — a small but significant group of individuals who hold Turkish citizenship, speak Turkish and live in Turkey. It came in the wake of the slaughter of six million Jews in Nazi Germany and the subsequent Nuremberg trials.

As we have seen from the section concerning genocide refusal, many academics reject there was any motive whatsoever by the central government to exterminate the Ottoman Armenians. Not every Turkish historian, for instance, refuses to use the word genocide.

They will accept that there are disagreements over what happened, but they believe their interpretation is closer to the truth.

Ermeni tehciri ve gerçekler, / Yusuf Halaçoğlu. – Version details – Trove

TSV Security, Defence a In particular, the paper will focus on the three wars, in which the Balkan states and the Ottoman Empire were involved during the second decade of the twentieth century the Balkan wars and the World War Iand the impact they had upon the educational activities of the two American Protestant colleges at Istanbul. Supplies were scarce, and many died of malnutrition and disease.

Those attacking will be arrested and sent to the Martial Court and will be punished by the heaviest penalty. He says that the town had an Armenian population of around 25, in One of halaaolu significant activities of Cemal Pasha was to gather Armenian orphans in an orphanage he founded in the Ain Toura Monastery and halao,u sure they were taken care of and educated Atnur Where they disagree This primary level of agreement attained among Turkish historians, where most accept the tehcir process was a tragedy that claimed thousands of lives, is lost when discussing the events in greater detail.

Annual Register to Baltic Techiri Chicago: We were unable to find this edition in any bookshop we are able to search.

The law about the migration of Armenians known as the Deportation Law was prepared on 27 May with the initiations of the Internal Affairs Minister Talat Bey and decided by the Assembly of Ministers on 1 June and put into force.

It was a tragedy of unspeakable magnitude. Home This editionTurkish, Book, Illustrated edition: What is often not known about these events of is that there were a series of courts-martial held for them.

These online bookshops told us they have this item: Official word and actuality are not necessarily the same thing. Separate different tags with a comma. Physical Description x, p. Lowry is a founding member of the Institute of Turkish Studies, was executive director at the time ermenii the Lifton letter, and is currently a member of the board.

Books by Yusuf Halaçoğlu

It said Remeni and logic command Turkey and Armenia to not be afraid of breaking taboos by working in a joint initiative. A recent cover feature for the Tempo current affairs magazine shows that there are myriad estimates.

Some, but not all, do describe the events of as genocide. The report of the Directorate of Yuuf of Tribes and Immigrants which organized the deportation contains striking information about the applications carried out about Armenian orphans during the transfer. The latest effort was almost successful: Those staying out of these will be transferred to their destinations by carts and mules or on foot.

Notes At head of title:

LA MAGIA DE URI GELLER PDF

Uri even gives advice on what to do if things go wrong The Uri Geller Trilogy is an unbelievable journey! Filled with mystery and controversy to get a deeper. – “Uri Geller: sa volonté plie le fer”; 15 December – Abracadabra [UK] – Vol. .. “Piezas metalicas dobladas por la accion del pensamiento” – p. Interview with Andrija Puharich; – Magia Moderna [Italy] – “Cronaca di un incontro. Explore Psychic Abilities / Psionics’s board “How to Do Telekinesis” on Pinterest. Examples of notable claimants of telekinetic ability include Nina Kulagina, Uri Geller, Matthew Manning, Godmen, and more. . Rituel gratuit pour éloigner mauvais œil de la maison Look Into My Eyes, TAROT, MAGIA Y BRUJERIA.

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I prodotti difettosi dovranno essere segnalati al Servizio Clienti entro 14 giorni dalla data di consegna, in questo caso le spese di spedizione sono a carico del venditore.

Well good for Uri Geller, he hasn’t told anything yet. Select a valid country. For additional information, see the Global Shipping Programme terms and conditions – opens in a new window or tab. It is only in recent years that Uri Geller has agreed to attend magic conventions as a guest speaker still maintaining the stance that he is not a magician doing magic tricks. There are 1 items available. In this exclusive trilogy you will find: Uri Geller now lives in Berkshire and has made a few movies, and acts as a psychic life coach.

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Uri (Geller)

He held it up for me to see and then placed it down again. Our goal is to be entertaining! Geller is a legend. Watch list is full. If on the other hand he is a magician or a trickster or a con-man, he is also phenomenal – the best there has ever been. Uri even gives advice on what to do if things go wrong He no longer performed traditional magic tricks or big illusions but rather mental mysteries that challenged his audiences that perhaps he truly did have strange powers!

Kalopoulos You can find this book in the internet.

Uri Geller – A bibliography

It was not long before the public and magicians began to take more serious notice dee this new phenomenon, as did the scientific fraternity. I need your help and support if I Back to home page. Discover the unique, uncensored presentations of the world’s most well-known, investigated and celebrated mentalist of our generation.

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I think he made many things happen with his abilities. There is no gimmicked apparatus involved, just pure showmanship that proves successful under nearly all conditions. No additional import charges on delivery. Geller’s career, there is no question as to the magnitude of his impact on the field. Descripcion Comentario In Andrija Puharich met a talented young Israeli named Uri Geller, whose psychic abilities had already made him well known in his homeland.

The seller hasn’t specified a postage method to United States. For additional information, see the Global Shipping Programme terms and conditions – opens in a new window or tab This amount includes applicable customs duties, taxes, brokerage and other fees. You will receive a special spoon, personally bent uro signed by Uri Geller along with another original autograph on the DVD’s cover. Please enter a valid postcode.

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And in the beginning Geller was certainly fooling the scientists. Famous around the globe for his mind-bending abilities, he has led a unique life Terms and conditions of the sale.

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ALOIS RIEGL STILFRAGEN PDF

Stilfragen: Grundlegungen zu einer Geschichte der Ornamentik (German Edition) [Alois Riegl] on *FREE* shipping on qualifying offers. This is a. Stilfragen by Alois Riegl, , available at Book Depository with free delivery worldwide. Stilfragen Grundlegungen Zu Einer Geschichte Der Ornamentik has 11 ratings and 2 reviews. M said: Alois Riegl discussed the evolution of ornament by trac.

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We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the aloos of such historical works.

Cassandra marked it as to-read Jul 12, Milton Andrews added it Sep 27, Within Riegl’s work as a whole, the Stilfragen constitutes his earliest general statement of principles, although his “theoretical thinking had not by any means reached maturity.

Sally rated it it was amazing Nov 30, Return to Book Page. Harriet rated it really liked it Jan 22, A view with most serious implications.

Find more at www. Books by Alois Riegl. Ann rated it really liked it Apr 08, To see what your friends thought of this book, please sign up.

It was therefore “a product of pure artistic invention,” [10] and not of “a simple compulsion to make direct copies of living organisms. He traced these processes by observing ornamental w Alois Riegl discussed the evolution of ornament by tracing how the basic element ‘lotus’ developed historically through different civilizations and how the artistic developments accumulated into Islamic Arabesque. Matilde Best marked it as to-read Dec 19, Marcos marked it as to-read Apr 05, Carla Mary rated it it was amazing Nov 02, Sisena marked it as to-read Jul 30, Estelle marked it as to-read Jan 01, Haely Yoon marked it as to-read Sep 21, Ravi Shankar marked it as to-read Aug 02, Sarah Al-Mutlaq marked it as to-read Aug 08, stildragen Hardcoverpages.

Stilfragen : Alois Riegl :

Guzel marked it as to-read Apr 11, rlegl Kawakoala marked it as to-read Sep 28, The Stilfragen is divided into an introduction, which sets out the purpose of the work, and four chapters, each on a theme in the history of artistic style. This book is not yet featured on Listopia. He traced these processes by observing ornamental works of different periods from Egyptians, Mycaneans, Greek, Roman, etc.

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Just a moment while we sign you in to your Goodreads account. It was published in Berlin in Published April 18th by Stilfeagen Books first published Alois Riegl discussed the evolution of ornament by tracing how the basic element ‘lotus’ developed historically riwgl different civilizations and how the artistic developments accumulated into Islamic Arabesque. This position is argued in explicit opposition to that of the “technical-materialist” school, according to which “all art forms were always the direct products of materials and techniques” [2] and that ornamental “motifs originated spontaneously throughout the world at a number of different locations.

Courtney added it May 04, Want to Stjlfragen saving…. As the technical-materialist position had attained the status of dogma, Riegl aloia that “the most pressing problem that confronts historians of the decorative arts today is to reintegrate the historical thread that has been served into a thousand pieces. Neben diesen Extreinsten unter den Extremen gelten schon als Vertreter einer gemassigteisen Anschauung Diejenigen, die den dekorativen Kunsten wenigstens soweit als die sogenannte hohere Kunst, insbesondere die Darstellung des Menschen und seiner Thaten und Leiden hineinspielt, eine historische Entwicklung von Lehrer Zu Schuler, Generation zu Generation, Volk zu Volk, ein Zuraumen geneigt sind.

The third chapter, “The Introduction of Giegl Ornament and the Development of the Ornamental Tendril,” traces an unbroken evolution of vegetal ornament from ancient Egyptian through to late Roman art.

DISTRUST HER SHADOW JESSICA STEELE PDF

Distrust Her Shadow By Jessica Steele – FictionDB. Cover art, synopsis, sequels, reviews, awards, publishing history, genres, and time period. Jessica Steele started work as a junior clerk when she was sixteen but her husband spurred Jessica on to her writing career, giving her every support while she. Distrust Her Shadow by Jessica Steele released on Apr 22, is available now for purchase.

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Distrust Her Shadow : Jessica Steele :

Your purchase benefits world literacy! Her husband spurred Jessica on to her writing career, giving her every support while she did what she considers her five-year apprenticeship the rejection years while jssica how to write. Her sentence construction is She published her first books in Distrust Her Shadow Jessica Steele Reshmi rated it liked it Jul 08, InJessica married with her husband, Peter and within a very short space of time they had moved from her hometown to the lovely area where they now live.

Harlequin May 1, Language: And continues to hold this threat over her so that he can see more of her. Leona rated it liked it Sep 16, Amazon Inspire Digital Educational Resources. Books by Jessica Steele.

Eatons Books and Crafts Published: New York, NY, U. But the assignment was not what it seemed- Darcy was the unwitting messennger in a dangerous blackmail plot!

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Thanks for telling us about the problem. Linah En rated it really liked it Apr 24, Read more Read less. Get fast, free shipping with Amazon Prime. He holds the steee of seeing Jane’s agency ruined if she doesn’t work for him.

Jean rated it really liked it Apr 21, Steele is one of the worst writers, in terms of syntax, grammar, etc. There’s a problem loading this menu right now. All she had to do was deliver a letter. Their house is built into the side of a hill, and has beautiful views over more hills and valleys. While Neve is a slavedriver, Darcy comes to see a more gentler side. Shows some signs of wear, and may have some markings on the inside. Sign In Register Help Cart.

A rated it liked it Jan 21, She hangs up on his calls and then even refuses to answer her door when he comes knocking. Trivia About Distrust Her Shadow.

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GEORGES LABICA PDF

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Books by Georges Labica (Author of Lenin Reloaded)

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LF347N DATASHEET PDF

LFN Texas Instruments Operational Amplifiers – Op Amps Op Amp datasheet, inventory, & pricing. LICENSE UNDER ITS PATENT RIGHTS, NOR THE RIGHTS OF OTHERS. Ordering Information. Product Number. Package. Operating Temperature. LFN. LFN Datasheet, LFN National Semiconductor Quad JFET Input Op-Amp Datasheet, buy LFN.

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Unless otherwise specified, the absolute maximum negative input voltage is.

LFN Datasheet(PDF) – TI store

These low cost JFET input operational amplifiers combine two. Any amplifier output can be shorted to ground indefinitely. Unless otherwise specified, the absolute maximum negative input lf3477n is limited to the negative power supply.

Our lfn datasheet uses cookies and similar kfn to provide you with a better service while lfn datasheet or datasbeet an order, for analytical purposes and to personalise our advertising to you. Operating Junction Temperature Range.

Operating Ambient Temperature Range. Each internally compensated operational amplifier has well ,fn high voltage Lfn datasheet input devices for low input offset voltage.

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Each internally compensated operational amplifier lfn datasheet well matched. However, if more than. These devices are available in single, dual and quad operational.

Output Short Circuit Duration Lfn datasheet 2. They feature high slew rates, low input bias and offset currents, and low offset voltage temperature coefficient. However, if more than one amplifier output is lfn datasheet simultaneously, maximum junction temperature rating lfn datasheet be exceeded.

The product does not contain lfn datasheet of the restricted substances in concentrations and applications banned by the Directive, and for components, the product is capable of being worked on at the higher temperatures required by lead—free soldering The restricted substances and maximum allowed concentrations in the homogenous kf347n are, by weight: RS Components Statement of conformity. Device Function Temperature Range.

The JFET technology datasheett wide bandwidths and fast slew rates with low input bias currents, input offset currents, and supply currents. The product detailed below complies with the specifications published lfn datasheet RS Components.

LFN Datasheet(PDF) – National Semiconductor (TI)

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ARTHRON COMPLEX ULOTKA PDF

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AKTA KESALAHAN KECIL 1955 PDF

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Tiada pemandu di dalam dan tiada nombor telefon ditinggalkan.

Malaysian Majlis Bandarayas can now enforce traffic laws. What they do can extend to your tenants as well.

Apa anda boleh buat jika ada yang meletak kenderaan mereka di hadapan rumah anda?

Tetapi bukan untuk pemandu kereta di atas. Gambar kereta yang diketak di hadapan pintu pagar masuk jiran. Criminal,General,Traffic Apa anda boleh buat jika ada yang meletak kenderaan mereka di hadapan rumah anda?

Jadi jika anda terperangkap dalam situasi di mana kereta diletak bersepah di persekitaran rumah anda atau anda pernah berada dalam situasi di mana pagar masuk rumah anda dihalang oleh kereta lain, jangan risau kerana dalam situasi ini, andalah pemenang keecil sini.

Kesalahqn pertama, adakah meletak kereta sebegitu salah di sisi undang-undang? Anda menghampiri kereta tersebut. Clarence Kuna clarencekuna gmail. All articles have been scrutinized by a practicing lawyer to ensure accuracy. Mungkin ada di antara kita yang teringin sangat untuk mengambil langkah yang lebih agresif seperti mencalar atau memecahkan tingkap keretanya. Kami tahu yang anda semua di sana suka bergurau bila tiba masa bercakap kecik mencalar atau memecahkan tingkap kenderaan yang diletak dengan tidak betul.

Walaupun polis tidak menunda kereta pemandu tersebut, namun satu sesi lawatan polis adalah kesalwhan untuk memberhentikan tabiat buruk pemandu terlibat.

Rasa marah menyelubungi anda. Sudah pasti ianya salah! Tetapi apa yang boleh anda buat jika kereta terbabit diletakkan di dalam perkarangan rumah anda, jauh dari jalan raya awam?

Gambar senarai saman yang dikeluarkan ke atasnya. Di bawah AKKjika sesiapa memasuki perkarangan rumah dengan sengaja tanpa alasan yang munasabah, mereka akan disabitkan bersalah di bawah Seksyen 22 dan boleh didenda sehingga RM Kemudian anda bersumpah untuk mencari satu jalan penyelesaian bagi masalah tempat letak kereta ini.

Keecil anda pernah berada dalam situasi sebegini keslaahan jika anda tidak dapat memandu masuk ke jalan yang dihalang kenderaan lain, anda pastinya terfikir apa yang boleh anda lakukan penyelesaian yang sah di sisi undang-undang ya! Namun jangan sekali-kali melakukannya kerana ianya salah di sisi undang-undang walaupun ianya sangat memuaskan. Seksyen 48 1 APJ Can you sue if someone breaks a pinky promise in Malaysia? Lagipun, kenapalah anda perlu berbuat begitu jika masalah ini dapat diselesaikan dengan menghubungi pihak berkuasa?

Can Malaysian condo managements block your access card if you don’t pay your fees? Kerana siapalah yang nak letak kereta merata-rata kalau kena bayar saman kan?

This article is for general informational purposes only and is not meant to be used or construed as legal advice in any manner whatsoever. Anda melepaskan satu jeritan yang cukup kuat, kesian anjing-anjing jiran terbangun dari tidur nyenyak mereka.

Akta Kesalahan-Kesalahan Kecil (Disemak – )

Pepper membuat aduan dengan MBPJ dan mereka kemudiannya menghantar seorang pegawai untuk memberi saman kepada pemandu kereta tersebut. Kenapa perlu menyusahkan orang lain? Tetapi kita faham yang ada di antara kita tidak mahu menghubungi pihak polis untuk menyelesaikan masalah ini kerana ianya menyusahkan dan bakal juga mewujudkan ketegangan di antara anda dan jiran anda. Kini anda terpaksa mencari tempat letak kereta yang lain dan tambahan pula, anda kena membuka pintu pagar anda dengan berhati-hati supaya kereta yang diletak di hadapan pagar masuk anda tidak mengalami apa-apa kerosakan.

How do you even put a company in jail?? Rupa-rupanya ada kesalahzn kereta yang diletak betul-betul di hadapan pagar masuk rumah anda! Akhirnya anda hampir sampai ke rumah anda tetapi anda tersentak seketika. Break a promise, break my heart.

Sedang anda memandu masuk ke kawasan perumahan anda dengan berhati-hati, anda menyumpah kerana banyak kereta di kiri dan kanan anda yang diletak secara berbahaya di tepi jalan.

Dia meneruskan perbuatannya sehingga saman yang terkumpul di atas namanya meningkat sehingga ke RM1, Seksyen 48 2 menyatakan bahawa:. Anda terfikir, kenapalah mereka tak letak kereta di perkarangan rumah mereka, kan banyak tempat.