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"Drugs and Cosmetics Rules, 1945" (PDF). Central Drugs Standard Control Organization.Archived from the original (PDF) on 31 October 2005.; A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context Recommendations for Drugs & Cosmetics Rules with context of Drug Schedules
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
Point of care (POC) documentation is the ability for clinicians to document clinical information while interacting with and delivering care to patients. [10] The increased adoption of electronic health records (EHR) in healthcare institutions and practices creates the need for electronic POC documentation through the use of various medical devices. [11]
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
The standards that are in effect since 1 December 2010, [4] are the Indian Pharmacopoeia 2010 (IP 2010). The Pharmacopoeia 2014 was released by Health Minister Ghulam Nabi Azad on 4 November 2013. [5] The Pharmacopoeia 2018 was released by Secretary, Ministry of Health & Family Welfare, Government of India. [5]
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. [1]
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
In two other studies of Cal/BD ointment, 1 patient of 19 (5.3%) had adrenal suppression, as did 5 patients of 32 (15.6%) after 4 weeks of treatment. In the latter study, it may be noted that patients used Cal/BD ointment on the body in addition to Cal/BD topical suspension on the scalp.