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Let’s learn how to write an ABSTRACT

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Let’s learn how to write an ABSTRACT

What you need to include in a research paper is ABSTRACT:
Now, why is the abstract important?: It essentially seduces the reader into reading the rest of your paper and provide a general understanding about the story inside. An abstract describes about what you do in your essay, whether it’s a scientific experiment or a literary analysis paper. Your abstract must summarize all of the parts of the paper by writing accurately, concisely, and includes only the most important content so that you can keep those readers seduced into reading your paper.

To write an abstract, conclude your paper first, then type a summary that defines the purpose, problem, methods, results, and conclusion of your work. After you get the details down, all that’s left is just to format it correctly. Since an abstract is only a summary of  your workdone, so it’s easy to accomplish!

So, before coming to structure of the abstract let’s talk about the couple of things you need to keep in mind before you begin to write it.

Getting your abstract started:

1. Write your paper first: Although an abstract goes at the beginning of the work, it acts as a summary of your entire paper. Put away writing your abstract for last, after you have already finished your paper.

2.  Review and try to understand any requirements for writing your abstract. The paper you are writing probably has some specific guidelines and requirements, whether it is for publication in a journal, submission in a class, or part of a work project. Before you start writing, first  refer to the guidelines, also about the  LENGTH,STYLE and REQUIRENMENTS.

3. Consider your audience. Refer to others persons as guide or mentor just to know, what changes you still have to do.

4. Verify the type of abstract. 

Now start writing your Abstract: There are total 5 parts of abstract, as given below. Purpose
Problem
Method
Result
conclusion

1. Identify your purpose.  The reader wishes to know why your research is important, and what’s the purpose of it. Example: “This study explains about Development and Characterization of the Paclitaxel loaded Riboflavin and Thiamine Conjugated Poly (propylene Imine) Dendrimer mediated brain delivery”

2. Explain the problem. Abstracts state the “problem” behind your work. What problems is your research trying to better understand or solve, also what is the scope , What are your main claim or argument? “Brain tumor is difficult to treat because of poor absorption of many potentially useful antitumor drugs through BBB (blood brain barrier).  Present study was aimed for developing and exploring the use of Paclitaxel- loaded Riboflavin and Thiamine Conjugated Poly (propylene Imine) Dendrimer for increase delivery of this drug across BBB.”

3. Explain your methods. Now this is the part where you give an overview of how you gifted your study. If you did your own work then include a description of it or If you reviewed the work of others, it can be explained in few words. “The developed conjugates were characterized using FTIR, NMR spectroscopy, electron microscopy drug loading, release, hemolytic, and ex vivo studies.”

4. Describe your results (informative abstract only).  This only for informative abstract, you will be asked to present the results of your study. What  you found(results)?, What answer did you attain from your research or study?, Was your theories or argument supported?, and what are the general findings? “The PTX-Tm-PPI and PTX-Rf-PPI showed more cytotoxic effect as compared to PTX and PTX-PPI with PTX-Rf-PPI exhibiting the maximum cytotoxic potential. Biodistribution studies confirmed about the targeting efficiency and higher biodistribution of Tm-PPI conjugates into the brain.”

5. Give your conclusion (in both descriptive and informative abstracts). This should end up your summary and give closing to your abstract. In it, deal with the meaning of your findings as well as the importance of your overall paper. “The result concluded that the riboflavin and thiamine conjugated PPI dendrimer has great potential to deliver significantly higher amount of drug to brain tumor for improved therapeutic outcome.”

Formatting Your Abstract:

1.Keep it in order.  Write your abstract in an order like first write introduction, body, and then conclusion. Many journals have specific style guidelines for the abstracts. If you have  been given a set of rules or guidelines, follow them to the letter.

2. Provide helpful information. Unlike a topic paragraph, which may be intentionally indefinite, an abstract should provide helpful explanation of your paper and your research.  Try to avoid using direct acronyms or abbreviations in the abstract and do not include tables, figures, sources, or long quotations in your abstract. “Brain tumor is difficult to treat because of poor absorption of many potentially useful antitumor drugs through BBB (blood brain barrier).  Present study was aimed for developing and exploring the use of Paclitaxel- loaded Riboflavin and Thiamine Conjugated Poly (propylene Imine) Dendrimer for increase delivery of this drug across BBB.”

3. Write it from scratch. Although your abstract is a summary but it should be written entirely separate from your paper. Don’t just copy-paste original sentences from paper, also avoid simply paraphrasing your own sentences, try to write your sentences using completely new vocabulary and phrases just to keep it interesting.

4. Use key words and phrases. If you want your abstract is to be published in a journal and people should be able to find it easily, then readers will search for definite queries on online databases in hopes that the papers, like yours, will show up. Also, try to use 5-10 important words or phrases key to your research in your abstract.
KEY WORDS PPI Dendrimer. paclitaxel. riboflavin. thiamine. Vitamins

5. Use real information. You want to represent people in with your abstract; it is the hook and eye that will promote them to continue reading your paper. On the other hand, do not reference ideas or studies that you don’t include in your paper to do this. Citing material that you don’t use in your work will misinform readers and ultimately lower your viewership.

6. Avoid being too specific. An abstract is a summary , you should not need to explain or define any terms in your abstract, a reference is all that is needed. Avoid being too explicit in your summary and stick to a very broad overview of your work and avoid terminologies. https://www.ncbi.nlm.nih.gov/pubmed/22994427
https://www.wikihow.com/Write-an-Abstract

Lets learn how can You summarize any Story/ article or Research Paper

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Lets learn how can You summarize any Story/ article or Research Paper

What is summarizing: Giving a short statement of the important points by removing all extra fat. Why is it important: It allows you to restate key information in a way that is short and in order.You can be do this amazing summarizing things by  using  your five fingers in five words or less in less than five minutes method as

WHO-WHAT-WHEN-WHERE-WHY
Finger 1. Write WHO was in the story/ article.
Finger 2. Write WHAT happened in the story/ article.
Finger 3. Write WHEN it happened.
Finger 4. Write WHERE it happened.
Finger 5. Write WHY it happened.
Now completing these, write HOW it happened in five words or less.
Now, The Summary Requirements:

Keeping in mind these, you can write your story/ article or Research Paper 1. Brief / concise: it must contain only important points.
2. Paraphrase : change the sentences without changing in the meaning.
3. Skim, Scan, key ideas : Skim (don’t go deep, make it simple and clear), Scan (can read just one min),key ideas(main points).
4. Write using notes: just pull out all the important points and write it in your own words. 5. Combine sentences: combine two or three sentences to make one, just to make it shorter. 6. Same order as passage: order of points must remain same.
7. Use connectives: use and ,or, but to combine sentences.
8. Use topic sentence in paraghraph: wright that one senctence  that can tell you full story/ article.
9. Use reporting verbs: when you are writing something, try to use report verbs like beg, admit, point out, demonstrate, examine.
10. Write nice title.

Drug Approval process-FDA

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Drug Approval process-FDA

The scope of this blog to give the overview of Drug approval process in US.

The regulatory agency of USA is FDA which has two bodies: CBER and CDER.
CBER stands for  Centre for biological evolution and Research and CDER stands for Centre for drug evaluation and research.  CBER agency deals with biological product whereas CDER deals with drugs and biological both. In general the drug (chemical) approval process in US can be divided into four parts, they are: 

  • Supplemental new drug application
  •  Abbreviated new drug application
  • Petitioned ANDA
  •  and New drug application

Abbreviated new drug application (ANDA): It follows the 505 b (j) pathway. Proposed drug candidate must be same with respect to following attributes compared to Reference listed drug (RLD). List-1

  • Active ingredient,
  • Indication
  • Dosage strength,
  • Dosage form,
  • Route of administration
  • Inactive ingredients

As per FDA, “A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.”

Bio-equivalence studies (to check rate and extent of absorption)  are conducted to ensure that proposed product is bio equivalent to RLD. Safety and efficacy studies are not required.  Certain differences in inactive ingredients are permissible. Few differences in the inactive ingredients are allowed in ophthalmic, Parenteral and otic formulations. Preservative buffer and antioxidants can differ from the RLD parenteral formulation. These excipients are called exception excipient. The difference in the excipient should not have any effect on safety and efficacy of drugs.

Supplemental new drug application: This application follows the 505(b2) pathways. It can be chosen if a proposed drug candidate has to undergo any of the changes mentioned in list-1. In addition to this, if any  switch to OTC product from prescription or any new combination of drugs, are evaluated, then it follows 505 b(2) pathway. If any change in active ingredients as new salt formulation or complex, then FDA can consider it for 505 b(2) pathways .

Petitioned ANDAs (submitted and approved under § 505(j)): As per the FDA: “A petitioned ANDA is a type of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than 1 active ingredient), and for which the FDA has determined, in response to a suitability petition under § 505(j)(2)(c), that safety and efficacy studies are not necessary for the proposed drug product.”
In short, applicants apply for 505 b(2), but FDA determines that safety and efficacy studies are not needed and drug product is reviewed under petitioned ANDA.

NDA (New Drug application): This pathway is used for new chemical entity which has  not been approved by the FDA. Rigorous pre-clinical and clinical studies (Phase I to Phase III) are required to establish PK-PD profile, safety and effectiveness of the drug candidate before submission to FDA. 

For better understanding about Drug approval process in different countries you can refer following blogs:
The Drug approval process in EU:
Drug Approval Process in China
Generic Products Approval Pathways: Paragraph Certification I, II, III, and IV:
Drug Approval Process in India

Ref
https://www.sternekessler.com/news-insights/publications/505b2-drug-approval-pathway-potential-solution-distressed-generic-pharmahttps://www.fda.gov/media/124848/download https://www.finnegan.com/en/insights/summary-of-fda-guidance-on-determining-whether-to-submit-an-anda-or-a-505b2-application.html https://www.sternekessler.com/news-insights/publications/505b2-drug-approval-pathway-potential-solution-distressed-generic-pharma



U.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination with erbitux® (cetuximab) (braftovi doublet) for the treatment of Brafv600e-mutant metastatic colorectal cancer after previous therapies

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U.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination with erbitux® (cetuximab) (braftovi doublet) for the treatment of Brafv600e-mutant metastatic colorectal cancer after previous therapies

Dec 18, 2019: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the effectiveness and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI® (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), subsequent one or two lines of therapy.

The FDA grants Priority Review to the medicines that may offer noteworthy advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for the decision by the FDA is in April 2020. https://www.pfizer.com/news/press-release/press-releaseetail/u_s_fda_accepts_and_grants_priority_review_to_snda_for_braftovi_encorafenib_in_combination_with_erbitux_cetuximab_braftovi_doublet_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_after_prior

Galapagos in collaboration with Gilead submits NDA to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment

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Galapagos in collaboration with Gilead submits NDA to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment

Dec 19, 2019: Galapagos NV  announced that its collaboration partner, Gilead Sciences,) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adult patients living with moderate-to-severe rheumatoid arthritis (RA).

A priority review voucher was submitted with the NDA, shortening the probable time for review. The NDA filing is supported by 52-week data from the global Phase 3 FINCH clinical program, which evaluated the efficiency and safety of filgotinib in 3,452 patients with moderate to severely rheumatoid arthritis.

According to the FINCH studies, filgotinib met its primary endpoints and demonstrated durable effectiveness and safety results across the multiple RA patient populations, including in people with previous inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and also, those who were MTX treatment-naïve. 

Safety results were reliable across the trials and advances reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients. https://fda.einnews.com/pr_news/505337222/gilead-submits-new-drug-application-to-u-s-food-and-drug-administration-under-priority-review-for-filgotinib-for-rheumatoid-arthritis-treatment

Oxidien Pharmaceuticals Announces encouraging Response from FDA on Proposed Development Plan

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Oxidien Pharmaceuticals Announces encouraging Response from FDA on Proposed Development Plan

Dec 19, 2019: Oxidien Pharmaceuticals, announced that it has received encouraging responses from U.S. Food and Drug Administration (FDA) regarding their proposed Phase 1/2 trial in secondary hyperoxaluria patients and other development plans for its lead drug candidate.
The FDA reviewed Oxidien’s IND enabling pre-clinical data, and the results from a prospective, randomized, double-blind, placebo-controlled healthy volunteer study that evaluates both safety and efficacy.

Before this year, Oxidien Pharmaceuticals, LLC, spun out the hyperoxaluria research division from Captozyme Inc., a microbiome contract development and the manufacturing organization.

Having raised a total of $5.7 million to support the development of novel oxalate-reducing enzymes, Captozyme recognized a solid foundation of data enabling a knowledgeable clinical program.
https://fda.einnews.com/pr_news/505257241/oxidien-pharmaceuticals-announces-favorable-response-from-fda-on-proposed-development-plan

Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

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Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Dec 18, 2019: Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel) and its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising independently formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with the relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.

This submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including the diffuse large B-cell lymphoma (DLBCL).

Recently, BMS presented data from this pivotal study at the American Society of Hematology annual meeting. Liso-cel is an investigational compound that is not approved for use in any of the country.

Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL that accounts for three out of every five cases.

Around one-third of patients with DLBCL relapse after receiving first-line treatment, and approx 10% have refractory disease.

In the past, median life expectancy for patients who relapse or are refractory to the current standard of care treatments is approximately six months.

Combining these approaches is a solution of delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-submission-biologics-license-ap

FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

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FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

Dec 18, 2019: Seattle Genetics and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV ™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer for the patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or also in a locally advanced or metastatic setting.

PADCEV (approved under the FDA’s Accelerated Approval Program ) is the first FDA approved treatment in the U.S. for these patients.

It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein situated on the surface of cells and highly expressed in bladder cancer. 

The FDA’s Accelerated Approval Program allows approval of a medicine that is based on a surrogate endpoint if the medicine fills an unmet medical need for the serious condition.

A global, randomized phase 3 confirmatory clinical trial (EV-301) is in progress and is also intended to support global registrations. https://www.oaoa.com/news/business/article_770940b8-3c8e-5154-9d92-40e44354226b.html

astellas.com/en/news/15511

Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

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Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

Dec 16, 2019: Novartis announced topline results from its pivotal global Phase III LUSTER-1and LUSTER-2 studies examing the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039).

The pooled analyses of the LUSTER trials did not meet the clinically relevant entrance for reduction in the rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of  doses (150mg / 450 mg).

The studies included patients who had incorrectly controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller. The entirety of these results do not support further development of fevipiprant in asthma. Fevipiprant, in general well tolerated, with treatment-emergent adverse events normally balanced across groups and comparable to placebo.

Company continues to invest into respiratory medicines with in-market products Xolair® (severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]), Ultibro® Breezhaler® (COPD), Phase III investigational products QVM149 (moderate-to-severe asthma), and QMF149 (moderate-to-severe asthma), as well as active research programs covering asthma, COPD and other areas of the high unmet need, such as idiopathic pulmonary fibrosis and sarcoidosis. https://www.novartis.com/news/media-releases/novartis-provides-update-luster-phase-iii-studies-patients-uncontrolled-gina-45-asthma

Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

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Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

Dec 17, 2019: Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all the government authorities required by the merger agreement.

Roche and Spark together will be able to appreciably improve the lives of patients through innovative gene therapies. 

This acquisition supports our long-lasting commitment in order to bring transformational therapies and innovative approaches to people around the world with serious diseases.

Spark Therapeutics, based in Philadelphia, Pennsylvania, is a fully incorporated, commercial company that is committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases, also Spark Therapeutics will continue to operate as an independent company within the Roche Group. https://www.roche.com/media/releases/med-cor-2019-12-17b.htm

Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

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Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

Dec 17, 2019: Pfizer Inc. and Astellas Pharma Inc.recieves the FDA approved (first and only oral treatment) supplemental new drug application for enzalutamide (Xtandi) to treat men with metastatic castration-sensitive prostate cancer (mCSPC).

FDA approved enzalutamide with three distinct types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and mCSPC.

The agency based its approval on results from the randomized phase III ARCHES trial which is designed to evaluate enzalutamide plus androgen deprivation therapy (ADT), compared with the placebo and ADT, in 1,150 men with mCSPC.

Across sites in the US, Canada, Europe, South America, and the Asia-Pacific region, patients were randomized to receive 160 mg of enzalutamide daily or placebo and continued on a luteinizing hormone-releasing hormone agonist or antagonist or had a history of bilateral orchiectomy. https://www.cancernetwork.com/news/fda-approves-enzalutamide-mcspc-treatment

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

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Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

Dec 17, 2019: AstraZeneca and MSD announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for the patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.

The NDA submission was based on the positive results from the Phase III POLO trial that results in a statistically significant and clinically meaningful improvement in progression-free survival and reduced the risk of disease progression or death by 47% based on a risk ratio of 0.53. 

Lynparza almost doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a average of 7.4 months vs. 3.8 months on placebo.

The advantage of maintenance with Lynparza was seen over and over across a range of clinically meaningful endpoints. From six months onwards, more than double the  patients treated with Lynparza showed no disease progression vs. those on placebo.

In patients with assessable disease at baseline, 23% responded to Lynparza vs.12% on placebo and had a median duration of the treatment in excess of two years (24.9 months) vs 3.7 months on placebo. https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html

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