Articles

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Narinder Singh*, Surya Prakash Gautam, NeelamKumari,Rupinder Kaur,Manpreetkaur
CT Institute of Pharmaceutical Sciences, Shahpur, Jalandhar, Punjab
^*pharmacist.narinder@gmail.com

ABSTRACT
Virosomes are reconstituted viral envelopes that can fill in as vaccines and as vehicles for cell conveyance of different macromolecules. The prospect of drug delivery and targeting systems utilizing virosomes is an intriguing innovative work field. Since virosomes are biocompatible, biodegradable, non-poisonous and non-autoimmunogenuic; endeavors have been made to use them as antibodies or adjuvants and also conveyance frameworks for drugs and organic for remedial purposes. The achievement of virosomal medicate conveyance relies on upon strategy used to set up the typified bioactive materials and fuse them into the virosomes. Virosome innovation could conceivably be utilized to convey peptides, nucleic acids or, then again qualities and medications like anti-toxins, anticancer agents, and steroids.

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BALVINDER SINGH¹*, PAWAN JALWAL ¹, VIKASH KUMAR RUHIL ², NEHA MINOCHA¹
1.Department of Pharmaceutical Sciences & Research, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, India
2. P.D.M. College of Pharmacy, Bahadurgarh, Haryana, India
balvindersinghpharmaco@gmail.com

ABSTRACT
B.Pharmacy course is one of the leading professional courses in India. Two types of examinations are prevalent in B.Pharmacy course. One is the sessional examinations for internal evaluation. Second is the semester end/year end examination. Each examination has its own importance. The student should be well prepared for appearing in the examination. Appearing in the B.Pharm. Examination is not only merely science but it requires amalgamation of science and art.

ABOUT AUTHOR
Purva Gupta.
IIHMR, New Delhi.
purvagupta456@gmail.com

New Domain: This problem arises when organisation has not handled similar project earlier and stake holders have no prior experience on the project.

New Technology / Challenging Technology: Selected Project involves use of new technology or new equipment or specially trained staff may pose delay in completion of task, thereby project.

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SHIVANAND *, SAYANTAN MUKHOPADHAYAY
Division of Pharmaceutical Sciences S.G.R.R.I.T.S
Dehradun, Uttarakhand  248001, India.
^*shiva3671@gmail.com

ABSTRACT:
The active pharmaceutical ingredient that is thermolabile and moisture sensitive in nature generally degraded in atmospheric condition and thus have reduced stability and self-life. Lyophilization is one of those techniques which is utilized effectively to improve such critical condition. It is the one of the emerging technology in themodern era, which is effectively involved in the preparation of several antibiotics (e.g., chloramphenicol, doxycycline) and anti-cancer drugs (e.g., doxorubicin, epirubicin). This technique effectively utilized the phenomenon of sublimation to obtained primary dried product followed by removal of excess amount of moisture by modulation of heat. This technique not only improved self-life of thedrug but also provides fast reconstitution and reduced the cost of storage and shipping. Inthis review article principle behind lyophilization, steps involved, formulation aspects, theimportance of lyophilization and detection of the end point in lyophilization along with recent advancementwas explained.

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MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

ABOUT AUTHORS
Tahseen Sameena*1, Prathima Patil1, S.P.Sethy*1
1Department Of Pharmaceutics.
Azad College of Pharmacy
Moinabad-Chilkur Road , Hyderabad- India
* tahseensameena1992@gmail.com
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ABSTRACT: -
The Human Genome Project (HGP) refers to the international 13‐year effort, formally begun in October 1990 and completed in 2003, to discover all the estimated 20,000–25,000 human genes and make them accessible for further biological study. Another goal of this project was to determine the complete sequence of the 3 billion DNA subunits (bases in the human genome). As part of the HGP, parallel studies were carried out on selected model organisms such as the bacterium E.coli and the mouse to help develop the technology and interpret human gene function. The DOE Human Genome Program and the U.S National institute of Health (NIH) National Human Genome Research Institute (NHGRI) together sponsored the U.S.Human Genome Project.”

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Pandey Noopur*, Mahara Kamal
Department of Pharmaceutics
Global Institute of Pharmaceutical Education and Research,
Kashipur, Dehradun,
Himachal Pradesh, India
* noopurpandey56@gmail.com

ABSTRACT
Dendrimers are macromolecules having highly branched, 3 D structure, nano scale architecture with monodispersity and high functionality. These properties make it attractive candidates as unique and optimum drug carriers for controlled release or targeted delivery. Dendrimer is a smart polymer and as a result of their behavior dendrimers are suitable for a wide range of biomedical and industrial applications and in medical applications such as drug delivery, tumor therapy, diagnostics etc. The field of dendrimers has recently emerged as the most commercially viable technology of this century because of its wide ranging potential applications in many fields such as: healthcare, electronics, photonics, biotechnology, pharmaceuticals, drug delivery, catalysis and nanotechnologies. The review aims mainly on the introduction, objectives, properties, synthesis and applications, in future aspects of dendrimers. Dendrimers help in achieving increased bioavailability, sustained, controlled and targeted release of drug. Thus present review focuses on the fundamentals of dendrimers and their use as drug delivery agents in treatment of disorders.

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UPENDRA KUMAR SINGH*, Mr. Sammer Rastogi, Dr. Manish Kumar Yadav
^*MASTER OF PHARMACY in QUALITY ASSURANCE
School of Pharmacy, Lloyd Institute of Management and Technology
Uttar Pradesh, India
* upendra.singh81@gmail.com

ABSTRACT Quality Risk Management (QRM) is a key component for access the product quality. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of Quality Risk Management (QRM) on the product and process design and its lifecycle. The concept of risk management was first applied in the financial and insurance sectors. This concept was systematically transferred and applied in the pharmaceutical industries in 2005 with the International Conference on Harmonization (ICH) and its publication of the ICH guideline Q9 on “Quality Risk Management”. The European Commission added this guideline as Annex 20 to the EU GMP guide in March 2008. This research was explored the risk identification, risk assessment and development scientific risk control measures during transportation of API from API manufacturing site to user site (formulation plant).

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