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Vol 10 No 4 (2022): VOLUME 10, ISSUE 4, 2022
Research
Research on Quality Control Strategy of CAR-T Cell Therapy Products based on QbD
Wei Chen, Wenmiao Tian, Yi Liang
Pages 62-74
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Abstract
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DOI
10.22270/ijdra.v10i4.565
Review
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
Palak Govani, Krupa Bahekar, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanki, Shrikalp Deshpande, Maitreyi Zaveri
Pages 1-7
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Abstract
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DOI
10.22270/ijdra.v10i4.523
Survey of the Jan Pariyojana Scheme in India and its impact on citizens during the previous decade
Evesh Kaul, Priyanka Gupta
Pages 8-12
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DOI
10.22270/ijdra.v10i4.537
Regulatory Prospective on Software as a Medical Device
Foram Chothani, Vinit Movaliya, Khushboo Vaghela, Maitreyi Zaveri, Shrikalp Deshpande, Niranjan Kanki
Pages 13-17
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DOI
10.22270/ijdra.v10i4.545
Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India
Khushali Patel, Utsav Patel, Khushboo Vaghela, Niranjan Kanki, Maitreyi Zaveri, Vinit Movaliya
Pages 18-23
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DOI
10.22270/ijdra.v10i4.546
The Legal and Institutional Framework of Market Surveillance and the Fight against Spurious, Falsely Labelled, Falsified or Counterfeit Product in West Africa: The Case of Togo
Sandra Wotsa VIDJRO, Fatima GUIET MATI, Serge-Antoine AMARI, Jean-Yves PABST
Pages 24-31
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DOI
10.22270/ijdra.v10i4.555
How to write standard operating procedures: values and a practical guide
Kidanemariam G/Michael Beyene, Solomon Nadew, Wassu Gedefaw Ali, Awot Gebregzabiher Gebrehiwot, Solomon Getachew Atsibeha
Pages 32-37
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DOI
10.22270/ijdra.v10i4.557
Global Medical Device Nomenclature: Basic concept and Five-Year strategy
Ayesha Siddikha, K. S. L. Vidyadhari, M. Beulah Manasa, N.L. Prasanthi, K. Venkateswara Raju
Pages 38-44
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DOI
10.22270/ijdra.v10i4.560
A study of Regulatory aspects on Registration of Orphan Drugs in US and EU
S. Vasantha Mounika, P. Ramya, M.S.L. Divya, S. Naga Swaroopa, K. Venkateswara Raju, N.L. Prasanthi
Pages 45-52
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DOI
10.22270/ijdra.v10i4.563
Analysis of emergency Drug Approval System in China and the United States under Public Health emergencies and its enlightenment to China
Wei Chen, Yi Liang
Pages 53-61
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DOI
10.22270/ijdra.v10i4.564
Pharmaceutical Regulation in Niger in 2021: Significant advances with the Harmonization Process
Fatima GUIET MATI, Abdoulaye Ousmane, Anne Cinthia AMONKOU - N'GUESSAN, Jean-Marie TRAPSIDA, Issaka SONDE, Maty ELH MAMANE, Serge Antoine AMARI, Jean-Yves PABST
Pages 75-87
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DOI
10.22270/ijdra.v10i4.566
A Comparative study of Regulations of Cell and Gene therapy in US, EU and India
A Tejaswini, N.L. Prasanthi, K.Venkateswara Raju
Pages 88-95
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DOI
10.22270/ijdra.v10i4.569
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Online ISSN: 2321-6794
Print ISSN: 2321-7162
CODEN (CAS-USA): IJDRAF
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