Current Regulatory Scenario for Conducting Clinical Trials in India

Sathish, Ramu B

doi:10.4172/2167-7689.1000140

Cited by 2 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…ICMR maintains Clinical Trial Registry-India (CTRI), a free online public record system for registration of clinical trials designed to track all ongoing trials (Ramu et al, 2015). Dossier is a file document submitted for the approval of new drug or drug product.…”

Section: Clinical Trial Processmentioning

confidence: 99%

A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

Madagoni¹,

Saidireddy²,

Himaja³

2017

IJAPSR

View full text Add to dashboard Cite

ABSTRACT:Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process & requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

show abstract

Section: Clinical Trial Processmentioning

confidence: 99%

A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

Madagoni¹,

Saidireddy²,

Himaja³

2017

IJAPSR

View full text Add to dashboard Cite

show abstract

“…As a result, less water is reabsorbed from the collecting ducts, boosting urine output by increasing the osmolarity in the lumen. It is frequently used to treat hypertension, congestive heart failure, symptoms of edema, and to prevent kidney stones [12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Analytical Method Development and Validation of Propranolol and Hydrochlorothiazide

Golchha,

B.Rajkamal

2024

Preprint

View full text Add to dashboard Cite

The active pharmaceutical components of Propranolol and Hydrochlorothiazide in their bulk dosage forms were to be measured using a unique, straightforward, responsive, and stable RP- HPLC method that was being developed and gradually validated. For the quantitative determination of Propranolol and Hydrochlorothiazide, a straightforward, specific, verified, and well-defined stability that exhibits gradient RP-HPLC approach has been developed. The Waters C18 column (150mm×4.6mm, 5mm particle size) was used for the chromatographic method, which involved isocratic elution with a mobile phase made up of orthophosphoric acid (0.1%) and acetonitrile (40:60% v/v). The instrument parameters called for a flow rate of 1 ml/min and a detection wavelength of 265 nm using the UV detector. The chromatographic method was expedited using the impurity-spiked solution. The proposed method's validity was examined in accordance with the international conference on harmonization (ICH) guidelines. The plotted calibration charts had linear regression coefficients of 0.999, indicating that their linearity was within acceptable bounds. The suggested approach is quick, easy, practical, and reasonably priced. It can be used for routine manufacturing sample analysis during stability tests and to confirm the caliber of medication samples during stability studies.

show abstract

Current Regulatory Scenario for Conducting Clinical Trials in India

Cited by 2 publications

References 0 publications

A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

Analytical Method Development and Validation of Propranolol and Hydrochlorothiazide

Contact Info

Product

Resources

About