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Regulatory Affairs Network

Marketing Regulation of Drugs in India

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Role of Regulatory Authorities in Marketing Regulation of Drugs in India

Approval of the drug product for import, manufacturing and marketing in India, its demonstration for safety and efficacy in humans is essential. The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E and Appendix I, IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945, describes the information/data required for approval of clinical trial and/or to import, manufacture, or market any new drug in the country. However, the requirements for approval of clinical trials and new drugs may vary depending on the nature of new drugs.

The whole 11 pages article is available for download at Repository section of FarmavitaR+.

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Standardization of Herbal Drugs

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Challenges in standardization in Traditional Medicine / Herbal Drugs

The use of herbs and herbal extracts to treat diseases has stood the test of time. Herbal products/traditional medicine are composed of many constituents and are, therefore, capable of variation. The variability of the plant material is due to different conditions of growth, harvesting, drying, and storage. The polarity of the solvent, the mode of extraction, and the instability of constituents may also influence the composition and quality of the extracts.

The whole 10 pages article is available for download at Downloads section of FarmavitaR.com.

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Intellectual Properties Rights

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THE ROLE OF INTELLECTUAL PROPERTY RIGHTS IN TRADITIONAL KNOWLEDGE: AN OVERVIEW

Intellectual properties (IP) are legal property rights over creations of the mind, both artistic and commercial, and the corresponding fields of law. Under intellectual property law, owners are granted certain exclusive rights to a variety of intangible assets, such as musical, literary, and artistic works; ideas, discoveries and inventions; and words, phrases, symbols, and designs.

The whole 4 pages article is available for download at Downloads section of Faramavitar.Net

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CALONYCTION MURICATUM

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A RARE HERB OF MADHYA PRADESH HAVING PIVOTAL IMPORTANCE IN FOLK REMEDIES

Kotlaiya is an important medicinal plant of the ancient system of healing. It is type of kantkāri, a medicinal plant widely used in Āyurveda in the treatment of respiratory diseases. It has been described as white variety of kantkārī. The present paper reviews the pharmacognosy, phytochemistry and traditional uses of the herb.

 

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India - Survey of Computer Skills

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India - Survery of 1st Year Pharmacy Students´s Computer Skills

A pharmacist in today's scenario has to use computers to perform many critical tasks. For example, they have to rapidly access patient and medication data, have to perform critical non-distributive activities, and document their actions as per norms. It is the likelihood that pharmaceutical computer applications will expand in the future.

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Acne Therapy

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ACNE: MYTHS, FACTS AND THERAPY 

Acne, although being a very common skin problem, leads to a lot of heartache and corresponding increase in expenditure on off the self-cosmetic products, which may or may not help. The present paper throws the light on the acne, its cause, facts, myths and finally the drug therapy, which are used in suppressing the acne. Also, attempt was done to collect the herbal therapy for the acne since they are safe, easily available and free fron major side effects.

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Dendrimers - Drug Delivery to Cancer

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200708large.jpg Dendrimers: A Novel Approach For Drug Delivery to Cancer

New drug delivery technology that could improve the treatment of cancer, avoid side effects and even report back on the success of treatment. Dendrimers belong to a novel and exciting class of highly branched three-dimensional polymers. 

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Proteomics

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Protein fingerprinting made easy by Croatian scientists

Proeomics Zagreb, 12.12.2007. - Combining some traditional experimental methods of molecular biology with computational methods of artificial intelligence, a group of researchers from Ruđer Bošković Instititute and Faculty of Natural Sciences and Mathematics from Zagreb, Croatia, demonstrated a novel approach for producing ‘protein fingerprints’ of diverse tissues. This result could lead to the development of new convenient methods in medical diagnostics.

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PHARMACOSOMES

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 PHARMACOSOMES: AN OVERVIEW

Various types of vesicular systems such as liposomes, niosomes, transfersomes, and pharmacosomes, etc, have been developed in the transport and targeting of active agents. Pharmacosomes are the colloidal dispersions of drugs covalently bound to lipids, and may exist as ultrafine vesicular, Micellar, or hexagonal aggregates, depending on the chemical structure of drug-lipid complex. 

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