GUIDELINES ON COMMON TECHNICAL DOCUMENT (CTD) 28.10.2010 GUIDANCE FOR INDUSTRY ON PREPARATION OF COMMON TECHNICAL DOCUMENT FOR IMPORT / MANUFACTURE AND MARKETING APPROVAL OF NEW DRUGS FOR HUMAN USE (NEW DRUG APPLICATION – NDA) DRAFT GUIDANCE This guidance documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO‚ FDA Bhavan Kotla Road‚ New Delhi – 110002 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE
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NESTLE: Background: Nestlé is the world’s largest food and beverage company (http://www.nestle.co.za/about_us/about_us.asp). At the end of 2004 Nestle sales amounted to over R86 billion and the company today employs more than 250 000 people around the world (http://www.nestle.co.za/about_us/about_us.asp). In South Africa‚ Nestle employs nearly 4000 people and operates over 12 factories (http://www.nestle.co.za/). Nestlé’s main objective is to manufacture the best quality and most innovative products
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Preparation of Consolidated Statement of Financial Position 1 The consolidation process • Before consolidating‚ it may be necessary to adjust subsidiary’s financial statements where: 1. The subsidiary’s end of reporting period is different to the parent’s. In such cases the subsidiary is required to prepare adjusted financial statements as at the parent’s reporting date. 2. The subsidiary’s accounting policies are different to the parent’s. In such cases the subsidiary is required to
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Preparation of Synthetic Banana Oil Eric Nelson Chem. 253-1: Deepali Rathore Lab 1: Preparation of Synthetic Banana Oil 9-24-10 Purpose To create Isopentyl acetate with no more than 10% isopentyl alcohol and no more than 2% acidic acid in its composition. Theory Esters are a chemical functional group that usually forms by loosing a hydroxyl group and having it replaced with an alkoxy group with the loss of hydrogen. Esters are most commonly produced by taking a carboxylic acid‚ and
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UVA-C-2297 July 28‚ 2009 DOG CONCIERGES‚ LLC: TRANSACTION ANALYSIS AND STATEMENT OF CASH FLOWS PREPARATION Part I Although he owned his own business‚ Jeff Birch was a financial novice. His passion was dogs‚ and he had finally made the move to start a specialty dog services business in an upscale section of a large mid-Atlantic city. In its first two years‚ Dog Concierges‚ LLC‚ had grown to about $650‚000 in sales. Historically‚ he had left all financial concerns in the hands of his sister
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Vol.1 FE Exam Preparation Book Preparation Book for Fundamental Information Technology Engineer Examination Part1: Preparation for Morning Exam Part2: Trial Exam Set INFORMATION-TECHNOLOGY PROMOTION AGENCY‚ JAPAN FE Exam Preparation Book Vol. 1 Table of Contents Part 1 PREPARATION FOR MORNING EXAM Chapter 1 Computer Science Fundamentals 1.1 Basic Theory of Information 1.1.1 Radix Conversion 1.1.2 Numerical Representations 1.1.3 Non-Numerical Representations 1.1.4 Operations and Accuracy
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Educational Preparation Donna Ishay Grand Canyon University Professional Dynamics NR 430 Melissa Adams June 8‚ 2014 Educational Preparation This writer will be exploring the many differences between a nurse with an Associates-degree in nursing and a nurse with a bachelors-degree in nursing. Quality patient care is positively affected on having a workforce of nurses who are established at a higher educational level (AACN 2013). In fact‚ it has been proven that there are fewer errors in
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INTERPRETATION PROJECT 1 Introduction: From the assigned text of Matthew 24:42-44‚ we find that the scriptures speak of the predictions and preparing for Christ’s second coming. To better understand how each event correlates with each other‚ I will give my interpretations of each central message and summarize what the events all had in common. Episode 1 In Matthew 24: 1-35‚ the central message is the signs of the end times. We see specific and broad signs as the time of the second
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Evaluation and Preparation of Pediatric Patients Undergoing Anesthesia Primary health care providers should play a leading role in the medical evaluation and psychological preparation of children before surgery or other procedures requiring anesthesia. The provider’s goal is to ensure that the child’s medical issues are clearly defined and that the physiologic impact and limitations imposed by each condition are well delineated. The primary care provider’s knowledge of the patient’s past medical
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Hypothesis: I predict that a change in the mass of ammonium nitrate will affect the temperature change. Method: 1. Set equipment diagram 2. Measure 30cm^3 water 3. Pour into polystyrene cup 4. Measure temperature 5. Weigh 1g Ammonium Nitrate 6. Put in cup 7. Hold and swirl beaker 8. Record min. temp. 9. Dispose solution separate beaker 10. Rinse cup 11. Repeat for 2g‚ 3g‚ 4g‚ 5g Equipment: Balance Ammonium Nitrate powder Distilled water Spatula Glass beaker 30cm^3 Measuring
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