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System of preliminary scrutiny by CDSCO at the time of receipt of application for approval of Fixed Dose Combinations

Fixed Dose Combinations (FDCs) refer to products containing two or more active ingredients used for a particular indication(s). As per Rule 122-E of Drugs & Cosmetics Rule, A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration are considered new drugs.

Further, a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. The development of FDCs is becoming increasingly high either to improve compliance or to benefit from the added effects of the two or more active drugs given together. They are being used in the treatment of a wide range of conditions and are particularly useful in the management of chronic conditions.

Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.

Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues
Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements
Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries
Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization
Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance. 

Effect Of Food On Pharmacokinetics Of Meloxicam

The primary objective of the study was to investigate the effect of food on the pharmacokinetics of MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessmentof bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence between administration in fasting and fed conditions.