ABSTRACT The CTD is a harmonized registration dossier which can be submitted into Europe, USA, Japan, Canada and Australia. CTD is used for Drug products for human use, Biotechnological products, Herbal products and drug filing. CTD is mainly consists of five modules. Central Drugs Standard Control Organization (CDSCO), India has also decided to adopt CTD format for technical requirements for registration of pharmaceutical products for human use. Implementation of CTD is expected to significantly reduce time and resources needed by industry to compile applications for global registration. KEYWORDS:  CTD, CDSCO, ICH, DCGI, NDA

ABSTRACT: This article explains the role of external advisory bodies in oncology drug development and regulation from a global perspective. It contains the role of external advisors of United States Food & Drug Administration, European Medicines Agency, Health Canada, the Japanese Pharmaceuticals & Medical Devices Agency & the state food & drug administration china in oncology drug development and regulation in each of jurisdiction was explained and mentioned. It gives the clear cut idea about the role of the advisory committee of the countries like USA, Europe, Canada, Japan & China and their regulation system for approval of oncology drug products in global pharmaceutical market. KEYWORDS: Oncology, Regulatory Bodies, Advisory Committee, Drug Regulation

ABSTRACT The purpose of this research work was to establish sustained release tablets of Atomoxetine hydrochloride. The tablets were prepared by direct compression technique using HPMC-K4M, HPMC-K100M, Eudragit RSPO, Ethyl Cellulose as Sustained release polymer. These SR tablets were evaluated by different parameters such as weight variation, friability, assay, hardness, thickness, swelling index, in-vitro drug release study. The F9 formulation (containing HPMC K100M : EC)are optimized on the basis of in- vitro drug release studies. KEYWORDS: Sustained release tablets, Atomoxetine hydrochloride

ABSTRACT: The oral route is the most preferred route, though preoral administration of drug has disadvantage like hepatic first pass metabolism and enzymatic degradation within the GI tract however trans mucosal routes of drug delivery ( i.e. Mucosal lining of nasal, rectal, vaginal, ocular, & oral cavities) offer distinct advantage over preoral administration because mucosa are permeable and well supplied with vascular and lymphatic drainage. Their other advantages include bypass of first pass effects and avoidance of pre-systematic elimination within GI tract. The present investigation highlights the formulation and evaluation of mouth dissolving films of Olmesartan Medoxomil, prepared by solvent casting technique. Film made up of different polymers but combination of HPMC E15 and PVA was optimized as final formulation. KEYWORDS: Olmesartan Medoxomil,β-Cyclodextrins, HPMC E15, PVA, Mouth Dissolving films, Solvent casting technique.

ABSTRACT: Developing a new drug required great amount of research work in chemistry, manufacturing, control, preclinical science and clinical trials. Every country has its own regulatory authority which is responsible of evaluating whether the research data support the safety, effectiveness and quality of new drug product and to enforce the guidelines which regulating the marketing of new drug. Similarly, Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. Medical devices which are used to treat different diseases and which can be used by physician in different surgeries must go through the regulatory process to check its safety and effectiveness before going through clinical trial and marketing. This article focuses on history, mission, statutory requirements, administration and related issues with respect to drugs and medical devices in United State of America (USA).  KEYWORDS:   Regulatory process, Regulatory authority, Clinical trial, Medical Device, USA

ABSTRACT: The   present   research   work   aims   to   formulation   of   floating   and   in-vitro   evaluation   of   acyclovir   floating   tablet   using   direct   compression method.   The   potential   ingredients   used   as   floating,   swallable   polymer   are   HPMC   K100   LV   and   Psyllium   Husk   with   gas   generating   agent Sodium   Bicarbonate.   Psyllium   husk   was   specially   treated   to   improve   its   direct   compression   property.   Simplex   lattice   design   was   used   to carry   out   optimization.   Seven   batches   were   prepared   using   three   independent   variable   F   lag   and   Cumulative   %   release   5   h&   10h   as independent   variables.   Regression   analysis   showed   significant   coefficients   at   P   <   0.05.   The   final   optimized   batch   was   generated   using polynomial   equation   and   2D   Plots.   Release   kinetics   of   optimized   batch   revealed   that   drug   release   mechanism   follows   non-   fickain, anomalous   diffusion   (n=0.5-0.85)   and   tablets   were   testes   for   3   month   accelerated   stability   study.   Cumulative   %   release   before   and   after Stability   batches   were   tested   by   t   test   which   shows   significant   result   tcal<ttab.   Thus   gastroretentive   floating   drug   delivery   tablets   of acyclovir using HPMC, Psyllium husk and Sodium bicarbonate shows promising drug delivery system. KEYWORDS:  HPMC K100LV, Psyllium Husk, Simplex Lattice design, acyclovir, floating, gastro retentive

ABSTRACT: A   stability-indicating   reversed-phase   high   performance   liquid   chromatography   (RP-HPLC)   method   was   developed   for   the   determination   of Bezafibrate,   a   drug   used   in   the   treatment   of   Hyperlipidemia.   The   desired   chromatographic   separation   was   achieved   on   a   ZORBAX   XDB C-18   (150*4.6)5µ   column,   using   isocratic   elution   at   a   228   nm   detector   wavelength.   The   optimized   mobile   phase   consisted   of   a   ACN: WATER   (60:40v/v,   pH   2.8   adjusted   with   10%   o -phosphoric   acid)   as   solvent.   The   flow   rate   was   1.5   mL/min   and   the   retention   time   of Bezafibrate   was   5.55   min.   The   linearity   for   Bezafibrate   was   in   the   range   of   5-40   μg/mL.   Recovery   for   Bezafibrate   was   calculated   & stability-indicating    capability    was    established    by    forced    degradation    experiments    .The    developed    RP-HPLC    method    was    validated according   to   the   International   Conference   on   Harmonization   (ICH)   guidelines.   This   validated   method   was   applied   for   the   estimation   of Bezafibrate in commercially available tablets. KEYWORDS: Bezafibrate, method validation, forced degradation, RP-HPLC, Hyperlipidemia