- Need for Positive Clinical Research Programs For Better Medical Treatments
Clinical research plays a vital role in the treatment discovery and drug development process. The new era hectic lifestyle has increased the frequency of chronic ailments globally.
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- Need for Regulatory & Compliance Services in Drug Development
Medical regulatory & compliance services today is a dynamic business sector with an aim to get the products to the market within reduced cost, time and at a commercially feasible label.
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- Need of a Biotech Clinical Laboratory in Clinical Trials
Keeping in mind the present day ailments and chronic diseases, the medical industry have gained immense significance. It is essential to keep the general mass free from disease and to arrive at advanced methods of drug development treatment and healing modalities.
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- Online Clinical Trials – Scopes for Mobile Enabled Clincial Trials Today
The rapid development of internet and advancements in software technology is proving to be beneficial to the medical landscape in many ways.
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- Phase I Clinical Trial
Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities.
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- Phase I Clinical Trial
Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities
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- Phase I Clinical Trial
Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities.
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- Putting Biometrics Technology to Advanced Usages
Biometrics can be defined as a body of medical science discipline that has certain technologies and methods of approval of an individual using processes for automatically verification of personal traits, such as face, hands, fingers, voice and eyes using prints, geometry as well as pattern recognition.
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- Recent Developments in Biometric Identification Systems
To elucidate in simple terms, Biometric identification systems are personal biological or physical scanning’s/measurements done about an individual.
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- State-of-the-Art Phase I Clinical Trial Facilities
Lotus Labs has independent Phase I clinical trial facility & the expertise to conduct First-In-Human Studies, Pharmacokinetic studies, Bio-availability & Bio-equivalence studies, Drug Metabolism studies, Dose Proportionality & Multiple dose studies & more.
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- State-of-the-Art Phase I Clinical Trial Facilities
Lotus Labs has independent Phase I clinical trial facility & the expertise to conduct First-In-Human Studies, Pharmacokinetic studies, Bio-availability & Bio-equivalence studies, Drug Metabolism studies, Dose Proportionality & Multiple dose studies & more.
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- US FDA issues norms on delaying a drug inspection,waits industry comments
"The US FDA has issued guidance to the pharma industry on circumstances that constitute delaying, denying, limiting, or refusing a drug inspection. The regulatory major is seeking industry comments to this effect by September 30, 2013. "
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- US FDA issues rules on Electronic Source Data in Clinical Investigations;Indian CROs view it platform to prove proofs
US Food and Drug Administration (FDA) has issued the guidance for industry on Electronic Source Data in Clinical Investigations. This guidance provides recommendations to sponsors, Contract Research Organisations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.
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- US FDA norms for clinical investigators, sponsors & to ascertain need for human studies for IND
"In a major development on the regulatory landscape for clinical trials, the US Food and Drug Administration (FDA) has now issued a guidance which is intended to assist clinical investigators, sponsors, sponsor-investigators and institutional review boards (IRBs)."
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- US FDA seeks industrys comments on new draft norms on ANDA submissions
The US FDA has sought the pharma industry's comments on its draft guidelines on ANDA (abbreviated new drug application) submissions ― Refuse-to-Receive Standards.
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- US FDA to reduce backlog of generic drug applications, increase inspections
With US Food and Drug Administration (FDA) planning to work towards reducing the backlog of generic drug applications under the Generic Drug User Fee Act (GDUFA), Indian pharmaceutical companies have however cited challenges like approval time for abbreviated new drug applications (ANDAs)– the applications filed for generic drugs and heightened inspection activities, as GDUFA requires stepping up number of foreign inspections.
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